Responsibilities:Site Bern agent of Globally Owned Processes Quality Management SystemSite Bern Ownership (Deviation Management System)Quality Trending in the area of responsibilitySupporting Quality relevant projects and initiativesExecutes trainings/awareness related to GMP standardsProvides training to area of responsibilityLeadershipThis role will partner closely with the Global Quality Systems and other Quality functions to continuously improve and standardize the quality processes and standards across the network in his area of responsibility.Qualifications:University degree or university of applied sciences degree in natural sciences (e.g. Biology, Chemistry or Pharmacy)3+ years Experience in Quality or manufacturing in a pharmaceutical GMP environment or equivalentKnowledge of current Good Manufacturing Practices (cGMP) principlesKnowledge of Authority RequirementsFluent in German and English Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
CSL Behring ist ein weltweit führendes Biotech-Unternehmen, das sich seinem Versprechen verpflichtet hat, Leben zu retten. In Bern entwickeln und vertreiben wir mit über 1'800 Mitarbeitenden lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten weltweit. Für unseren Standort Bern suchen wir einen/eine
Stellvertretenden Teamleiter/in Energie und Reinmedien Als erfolgreicher Stellvertreter/in des Gruppenleiters Energy und Clean Utilities sind Sie für die Versorgung des Standorts Bern mit Schwarz- und Reinmedien zuständig.Insbesondere sind Sie für folgende Hauptaufgaben zuständig:Stellvertretung der Gruppenleitung mit 8-10 MitarbeitendenFachliche Verantwortung u.a. für die Bereiche der Reinmediensysteme, u.a. Wassersysteme PW, HPW und WFI, ReindampfPlanung der Instandhaltung und der WartungsunterbrücheBegleitung und Überwachung von externen PartnernAlarmpikett (1st und 2nd Level) 24/7Störungsbehebung, Durchführung von Wartungen, Betreiben der zugewiesenen AnlagenOptimierung des AnlagenbetriebsAufrechterhaltung des qualifizierten Zustands der Anlagen nach cGxPUrsachensuche und -dokumentation bei Abweichungen, Störungen, ÄnderungenBearbeitung der Wartungsaufträge im SAPWeiterentwicklung der Instandhaltung und der damit verbundenen Planung, Optimierung und Steuerung der AbläufeMitarbeit und Umsetzung bei Abläufen/Vorgaben zur Arbeitssicherheit inkl. ArbeitsfreigabenWer Sie sind:Abgeschlossene Berufsausbildung zum Sanitär mit Fokus auf Planung und Weiterbildung zum Instandhaltungsfachmann/frauMehrere Jahre Berufserfahrung im Bereich Unterhalt oder TechnikErfahrung im GMP-UmfeldGutes Durchsetzungsvermögen gepaart mit TeamgeistKommunikationstalentSehr gute organisatorische FähigkeitenSpricht fliessend Deutsch und gute Kenntnisse des Englischen (Wort und Schrift) Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Online-Bewerbung und Ihre vollständigen Bewerbungsunterlagen (am besten in einem Dokument zusammengefasst) . Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
The Senior Payroll Specialist position is responsible for payroll processing for CSL Swiss payrolls. Reporting to the Senior Payroll Manager Switzerland, the specialist is the key point of contact and SME for the payrolls they support.The position works closely with the Payroll Vendors to support processing of payroll, providing all appropriate payroll input, ensuring integrations are delivered and validating data before it is transferred to the vendor. Accountable for responding to queries from the payroll vendor and investigating any anomalies identified through auditing. Working closely with the Global Payroll Process Lead to help identify process improvements related to their payrolls, document requirements and support payroll testing.ResponsibilitiesEnsures payrolls are processed accurately, on time and in accordance with all federal, state/canton, local and regulatory requirementsFirst point of contact for Swiss payroll related matters, responds to complex employee payroll queries. Manages SNow ticket queue to ensure employee queries are answered within agreed SLAs and with attention to qualityInterprets policies and regulation regarding leaves, disability, allowances, one time payments, garnishments etc and works closely with payroll vendors to ensure they are applied through payroll and settled correctly Maintains knowledge management articles to ensure they are up to date and supporting employee needs Ensures any regular finance, compliance and audit reporting is delivered as per agreed timescales. Assists with audits and reconcilliations of payroll data as requiredReviews payroll policies/ procedures and ensures that the payroll calendars and processing schedules are consistent with organizational policiesWork with the Global Payroll Process Lead to define Payroll requirements related to payroll projects or enhancements. Perform User Acceptance Testing and document results, ensure user guides are updated appropriatelySupport the CH Payroll Manager to ensure that CSL meets its compliance with all federal/state/canton and regulatory requirements.Other Payroll related activites as directed by the managerQualifications & ExperienceBachelors in HR/Accounting degree or Diploma in payroll is preferred4-8 years of experience in Payroll with processing end to end payroll for Swiss payroll for at least 2000 employees total.Exposure to taxation, audit and compliance would be a plus. Strong payroll management, stakeholder management and communication skills. High level analytical and problem solving capability.Strong process management and business process analysis competencies and demonstrated ability to support complex HR/Payroll modelsEnglish and German language required Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
Als Mitarbeiter/in in der Berufsbildung der Lernenden Laboranten EFZ, sind Sie mitverantwortlich für die Ausbildung sämtlicher Laboranten EFZ, Fachrichtung Chemie, das sind zurzeit 9 Lernende verteilt auf 3 Lehrjahre.Zu Ihren Aufgaben zählen:Durchführung von Ausbildungskursen im Lehrlabor (Grundausbildungsinhalte wie Titration, Fotometrie, HPLC und Synthesen)Vermittlung von Theorie zu Methoden und Geräten für die Instrumentalanalytik und GrundausbildungDokumentation und Bewertung der Zielerreichung der Lernenden nach VorlageAusarbeitung von Ausbildungsversuchen im Bereich der Instrumentalanalytik (HPLC, UPLC, GC und NIR)Erstellung und Optimierung von AusbildungsunterlagenBei Bedarf Nachhilfeunterricht in BerufskundefächernMitarbeit bei der Durchführung von Informationsveranstaltungen, Schnupperlehren und der Rekrutierung neuer LernendenQualifikationen, die Sie mitbringen sollten:Abgeschlossene Lehre als Laborant/in EFZ, Fachrichtung ChemieErste Erfahrungen im Umgang mit Lernenden sind von Vorteil , jedoch nicht Bedingung Kenntnisse in der Grundausbildung und/oder der Instrumentalanalytik (z.B. Titration, Fotometrie, Synthese, HPLC & GC)Motivierte, kommunikative, zuverlässige sowie engagierte PersönlichkeitFreude an der Arbeit mit aufstrebenden, jungen MenschenÜber diese Position:Wir bieten Ihnen eine vielseitige Position mit der Möglichkeit, bei der Ausgestaltung unserer Laborantenausbildung aktiv mitzuwirken. Als Mitarbeiter/in in der Berufsbildung haben Sie viele soziale Kontakte und können Ihrer Passion für die Ausbildung von Jugendlichen nachgehen. Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
Reporting to the Head of CMO Quality, the Manager, CMO Quality is responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and to provide quality oversight for outsourced operational activities (e.g. API, Fill/Finish, Packaging). Focus of this QA role is to work on a regional basis (EMEA or Americas) with CMOs, support cross-business unit peers (CSL Behring, CSL Seqirus, CSL Vifor) and cross-functional teams to assure CMO Commercial Readiness (Tech Transfer) and CMO Operations. Core activities include developing and enforcing Quality Agreements, supporting CMO Changes and Deviations, resolving quality issues and reviewing of Quality Performance KPI's. The Manager may provide on-site support at CMO's if needed.This position will represent and lead CSL Quality in Operational/Pre-Campaign Meetings. Relationship management with our key CMO partners is a core responsibility of this role.This role is Global in nature and this individual will need to collaborate across the Global Quality Team as well as with CMO partners to assure that our Quality Assurance programs are implemented consistently across the network. Role and responsibilities Interface: Establish Collaborative Relationship with CMO and CSL MAH stakeholders (CMO Operations, Supply Chain, MAH Batch Release/QP) to ensure CMO Quality Oversight, Strong Quality System and Product Supply. Serves as primary regional interface and point of communication for assigned CMO's.As such, responsible to partner with CMO and MAH stakeholders to ensure strong business partnership and resolution of issues.Strives business continuity in partnership.Ensure CMO Quality system alignment with corresponding CSL site owner.Support operational effectiveness and partner with External Supply Operations. Quality Contract: CMO Quality Agreements Initiates, Manages (writing, editing, reviewing, updating, routing) and Negotiates CMO Quality Agreements.Ensure that all appropriate regulatory guidelines are represented in the Quality Agreement as well as oversee those from a day-to-day perspective:Assure CMO is approved.Execution of authorized activities and the accuracy and quality of records.Maintain GxP training.Support any recall operations for medicinal products together with the CSL responsible groups and the CMO.Ensuring that relevant customer complaints are dealt with effectively together with the CSL responsible groups.Deviation management and CAPA: Review, assess (by consulting relevant MAH SMEs), challenge and approve CMO deviations to ensure product quality and compliance. Continuously improve processes in order to prevent deviations and to increase quality and compliance standards.Changes; Review, assess (by consulting relevant MAH SMEs), and respond to CMO changes; Share relevant information with MAH SMEs whenever CSL changes need to be initiated.Review/approve controlled cGMP documents including SOPs, material specifications, investigation protocols/reports, process validation protocols/reports, as applicable.Ensuring that any additional requirements imposed on certain products by national law are adhered to by the CMO and CSL. Performance: Oversee, track and report on regional CMO quality performance Develop, monitor and report CMO Quality performance through globally aligned KPIs.Identify CMO issues that present a trend.Ensure adequate corrective actions are implemented at the CMO. Escalation: Escalation Resolution Escalate Quality issues during Joint Operation Meetings.Escalate Quality issues and emerging trends to Sr. Manager, CMO Quality, key stakeholders and relevant global functions.In case of major CMO Quality issues, ensure that all required operational areas are fully aware of results and progress to ensure MAH can validate to root cause investigations and CAPAs.Provide decision support where necessary to the CMO and MAH Batch Release Team in response to issue management. Standardization: Maintain standardized Quality Oversight processes with CMO and CSL Sites Act with applied consistency of CMO Quality process and governance.Drives the integration of the CMOs to CSL's quality system governance by striving for harmonization across quality system handling (e.g., change management, Product Technical Complaints, Batch Record Reviews, Recalls, Deviation etc.) to ensure we work hand-in-hand.Follow standardization across CMOs (e.g Change Management, Product Technical Complaints, Batch Record Reviews, Recalls, Deviations etc.) to ensure comparability btw. CMOs. Quality Representative: Represents QA in cross-functional project teams such as CMO Operations, commercial readiness, and process improvements. Acting as the SME for CMO Management organization in the dedicated cross-functional CSL teams.Participation and representation of Quality at joint Operational Meetings.Responsible for preparing the quality content for the Joint Business Review Meeting.Lead Quality related topics at off-site visits and teleconferences for discussion and review of CMO performance and cGMP compliance.Leads Quality related sub-projects within CSL and in connection with the corresponding relationship. Quality Person-in-Plant: Provides on-site presence as necessary. Lead the on-site resolution of Quality concerns at CMO Operations and CMO Commercial readiness phase.Enhance CMO Quality Maturity.Execute Quality Road Maps as necessary.Support CSL Product related regulatory inspections at the CMO as needed, assess and communicate any potential impact on CSL business.Support Regulatory Observations related to CSL product as necessary. Future Growth: Manage intake of new CMO Projects and Initiatives Provide commercial readiness (during Tech Transfer phase), product launches and submission support as necessary. Manager: Branding Responsibilities Be a respected manager acting consistent with the overall ESQ partnering strategy and culture.Maintains knowledge of new/updated regulations and industry trends and continuously monitors CMO quality and compliance towards those.Represent the CMO Q-Oversight function in authority inspections, corporate audits and self-inspections as assigned.Perform additional tasks as assigned. Minimum Qualifications: B.S. degree in relevant business or science, or equivalent education and experience. Minimum of 5 years' experience in a GxP environment in the pharmaceutical industry.Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.Strong industry and quality system knowledge (internal and external) experiences within the industry.Must be comfortable working in a global, matrix organization.Experience in CMO business highly preferred.Strong organizational skills.Fluent in English and German (written and spoken). Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
Die mikrobiologische Qualitätskontrolle ist essenziell, um die Sicherheit von pharmazeutischen Produkten für die Patienten zu gewährleisten. Wenn Sie diese verantwortungsvolle Aufgabe übernehmen möchten, suchen wir Sie am Standort Bern als Leiter/in in der mikrobiologischen Qualitätskontrolle MBQC2.Als Leiter/in des hochmotivierten und ausgeglichenen Teams der QC Mikrobiologie MBQC2, sind sie verantwortlich für 14 direct reports. Diese Verantwortung umfasst neben den personal- und administrativtechnischen Aufgaben, die Weitergabe an Expertenwissen im Bereich der klassischen Mikrobiologie, regelmässige GMP Tutorials und Methodenschulungen. Sie fördern und unterstützen Ihre Teammitglieder und erklären die Hintergründe der Qualitätskontrolle. Umsomehr sind Sie für die operative und rechtzeitige Bearbeitung der Proben innerhalb des Teams verantwortlich und Sie stellen sicher, dass die pharmazeutischen Drug Substances, Umgebungs- und Utilitiesmonitoringsproben in Bezug auf die bakterielle Belastung vollkommen sicher sind. Zu Ihrem Bereich gehören ebenfalls die Tests der mikrobiellen Integrität von Proben.Werden Sie Teil unseres Teams und tragen Sie dazu bei, den Patienten eine wirksame und qualitativ hochwertige Behandlung mit den Produkten von CSL Behring zu ermöglichen.Verantwortlichkeiten:Fachtechnische- und Personalbetreuung der Laborgruppe mit 14 MitarbeitendenSicherstellung der GMP compliance und Alignment mit Reliability StandardsVerantwortung für mikrobiologische Tests und GerätschaftenKoordination und Planung der Aktivitäten mit entsprechenden FunktionsgruppenSicherstellung von korrekt durchgeführten Reviews und Audittrails gemäss ALCOA Prinzipien der GDocPUrsachenanalyse bei möglichen Abweichungen und Verantwortung für den rechtzeitigen Abschluss, sowie für sachgerecht definierten Folgeaktionen, um reoccurence zu vermeidenFührung von GMP-Schulungen und Sicherstellung der Qualifizierung der MitarbeitendenOptimierung von bestehenden Methoden und Verfassen von neuen Methods SOPs, sowie Implementierung von ÄnderungenDefinieren und Verfassen von RisikobewertungenVoraussetzungenBSc, MSc oder PhD in Mikrobiologie, Molekularbiologie, Molekularökologie oder Labortechniker/in, Laborant/in, Biologisch-technische/r Assistent/in (BTA), Medizinisch-technische/r Assistent/in (MTA), mit langjährigen Erfahrung im Bereich der mikrobiologischen Qualitätskontrolle in kontrollierten UmgebungExzellentes Verständnis für Gute Praxis und sehr gute FDA, EMA, EP/USP Fachkenntnisse in Bezug auf mikrobiologischen StandardmethodenSehr Gutes Verständnis der Hygiene und der aseptischen ProzesseAnalytisches DenkvermögenOperatives Denken und Handeln, sowie Fähigkeit Prozessverbesserungspotenzial zu erkennen und zu implementierenFührungserfahrung und FührungskompetenzFünf Jahre QC Mikrobiologie Erfahrung im kontrollierten UmfeldErfahrung in Kunden- und Behördenaudits
Wir bieten Ihnen eine verantwortungsvolle und abwechslungsreiche Tätigkeit in einem dynamischen Umfeld mit der Möglichkeit zur beruflichen Weiterentwicklung. Wenn Sie sich durch eine präzise und analytische Arbeitsweise auszeichnen und Freude an der Arbeit mit Labor haben, freuen wir uns auf Ihre Bewerbung! Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
As a successful C&Q Engineer you ensure that Commissioning and Qualification are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing commissioning and qualification for CAPEX- and OPEX-projects at CSL Behring.In detail, your responsibilities include:Planning, coordination and execution of all phases for commissioning and qualification of GMP manufacturing systems according to local and global procedures and standards as well as legal requirements.Facilitating the development, performing review and approving technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)Development of C&Q verification documents including but not limited to Commissioning/ Qualification plans, FMEA, IQ, OQ as well as for the execution of verification activitiesCoordination and oversight of vendor FAT/SAT, commissioning activities in collaboration with internal and external partnersPlanning and execution of PQ's including sterilization / depyrogenisation cycle development, Smoke Study, Temperature/Humidity mappingAssessing and handling of Change Controls, CAPAs and Non-Conformances related to qualification topicsWork collaboratively with all stakeholders, Process Engineering, Project Delivery, Execution Systems, PALM Validation, PALM Stability, Value Streams, R&D, QC staff and others, to ensure that activities are planned and delivered in an efficient timeframeProvide support and management to the multi-site projects to deliver on the company key CapEx projectsWho you are:Master degree in a relevant science or engineering disciplineProven work experience in biotech or pharma company in an cGxP environment and/or C&Q equivalent positionExperience and knowledge in sterilization / dehydrogenization is a plusKnow-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelinesExcellent written German and EnglishAbility to communicate clearly and effectivelyAnalytical thinking and problem-solving abilitySelf-time managementExcellent team player Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
This is a 12 month Fixed Term contract to cover employee medical leave of absence at the Bern, Switzerland manufacturing facility.Based at Bern or St GallenThe Site Learning Partner is a highly collaborative role that applies learning expertise and business knowledge to develop and deliver on a learning strategy for their designated site to drive business outcomes. This individual will serve as a true partner to the business understanding their strategies and learning needs across the organization. They will conduct learning needs assessments, develop associated learning plans, and partner with the Learning Innovations and Solutions team to develop modernized and relevant content to increase workforce capabilities and maintain compliance. Under direction of the Head of Manufacturing Site Learning Partners, this individual will execute on a broader strategy to drive business outcomes. This role works independently for their designated site and will need to have strong project management and individual accountability to drive value.This role conducts learning needs assessments and identifies appropriate solutions (learning or other) to achieve performance goals. The learning partner will work within annual budgets for their respective function to deliver on learning goals. They will also evaluate results/outcomes and adapt learning plans as needed. The learning partner may also participate in local inspections as needed and may be responsible for ensuring regulatory compliance subject to inspections by FDA, EMA and/or other regulatory bodies. This role will also provide learning consultation and support for local or functional pilot projects, improvement initiatives, and key process changes. They may interface with HR Learning and Development to assess learning needs and deliver learning plans.This individual will work closely with LMS administrators for the designated site and will support LMS administration activities as needed for their designated site.Key Responsibilities:Provide input into the Manufacturing Learning StrategyCultivate deep business knowledge to inform the learning strategyBuild strong relationships with functional leaders/stakeholdersAssess learning needsEach year, build a plan for learning content based on the needs assessmentUnderstand the nuances for sub functions and how that may impact the learning plansExecute on the Functional Learning StrategyBased on the strategy and learning needs, build out a plan to build and enhance training for the functionInvestigate and leverage modernized learning solutions and look to upgrade end user experiences in conjunction with the Learning Innovations and Solutions teamDeploy Effective and Efficient Learning SolutionsPartner with Innovations team and functional areas of support to assist with learning options Determine solution recommendations that are scalable across the enterprise Evaluate Learning Program Effectiveness and Compliance; Continually Improve Understand the effectiveness of learning programs through assessments, surveys, and feedback mechanisms and work with the team to continually improve on learning solutions. Assist with curriculum management; advise and support functional leadersSupport evaluation of existing curricula to ensure right-sized, value-added solutionsStay abreast of compliance metrics to understand and mitigate issues/gaps associated with compliance. LMS AdministrationProcess Learning Management System tickets as needed for updated learning assignments, curriculum updates, and new content.Supports DR/CAPA, Change Control, Inspection Readiness, and Continuous ImprovementSupports deviation investigations, business change controls and CAPAs related to training/learningSupports site and functional audits and inspections as requiredSupports responses to internal or external audit findings, and takes appropriate actions to ensure GXP compliance, as related to training/learningTravel 10-20%, primarily within Switzerland.Qualifications, Skills and Experience:-Bachelor's degree; areas of concentration could include but are not limited to education, human resources, sciences or other areas of study supportingpharmaceutical work.Experience within Manufacturing or prior experience in Learning Management in an industrial setting such as pharmaceutical manufacturing or support, LMS administration, content creation and management.Prior experience working with learning applications and competency with adult learning theories is a plus.
Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
We are seeking a quality leader for our plasma fractionation and finished dosage form manufacturing site located in Bern, Switzerland. For this role we are seeking someone who can lead change, partnering across the organization matrix on modernization and continuous improvement initiatives to assure sustainable compliance and operational efficiencies. The successful candidate will be able to thrive in a fast-paced environment while collaborating with local and global colleagues to assure the long term, sustained future for the Bern site.In this role and in line with CSL's Global Quality strategy, you will develop and lead the Site Quality function for CSL Behring AG, Bern, to assure appropriate quality of the pharmaceutical products manufactured and released under the responsibility of CSL Behring AG, Bern.Furthermore, you will:Align with the Decision Support Lead Quality & Technical Responsible Person to ensure all requirements of the FvP are met.Collaborate with Global Clinical Safety and Pharmacovigilance, to monitor and control drug safety in relation to the quality of the pharmaceutical products.Lead and have the managerial responsibility for the Site Quality Department and collaborate with all Global Quality Management functions, including Quality Control.As a member of the Bern Leadership Team, you will apply CSL's global Quality standards and practices within the local Pharmaceutical Quality System and enforce their implementation at CSL Behring AG, Bern.Role and responsibilities:Ensure the site execution of Global CSL quality strategies.Develop, implement and manage supporting local strategies, budget, standards, structure and culture for the CSL Behring AG, Bern Quality department.Ensure product and facility compliance with GMP requirements of relevant regulatory bodies in all target markets.Provide leadership, management, and support to ensure the implementation and ongoing operation of a functional and effective Quality organization at CSL Behring AG, Bern. This includes a clear definition of responsibilities for Quality Assurance and Batch Release aspects.Contribute to the development of interfaces and collaboration between Quality Assurance, Quality Control, Value Streams, Maintenance & Utilities and relevant other functions, e.g. Pharmacovigilance, Regulatory Affairs, and R&D and other parts of the CSL business (CSL Plasma and other manufacturing sites).Engage, motivate and develop Site Quality staff and address personnel issues as they arise.Ensure adequate resources (budget and headcounts) for efficient quality management in the respective functional areas.Review, approve or reject specifications, master manufacturing documents & procedures, sampling instructions, test methods and any other procedures with an impact on product quality (either directly or via delegation to an appropriately qualified and experienced person within the Site Quality department, in collaboration with the respective Value Streams or support functions).Ensure establishment of records and their retention according to need and applicable regulations, in collaboration with the respective Value Streams or support functions).Ensure the implementation and execution, directly or via appropriate delegation according to CSL's global Quality Management System, of an efficient and effective quality assurance system in all GMP relevant areas to meet regulatory standards in Switzerland and in the target markets for the pharmaceutical products.Ensure execution of Management Review of quality performance and Annual Product Reviews / Product Quality Reviews;Ensure that cGMP compliance and all factors that may affect product quality are monitored.Contribute to drug safety, especially regarding the pharmaceutical quality of drugs, incl. the execution of all necessary measures in case of complaints and possible recalls. Ensures the development of suitable measures for the limitation of possible negative impacts.Ensure an adequate inspection management process, this includes adequate preparation to enable a positive execution of national/international regulatory inspections and other third-party audits. Initiates the analysis of the inspection results as well as corrective/preventive actions and ensures that the responses to authorities are provided in a timely manner and the commitments are consistent with operations at other CSL facilities.Support R&D product improvement initiatives.Represent the company towards authorities (Swissmedic, FDA and other agencies) in all questions relating to the product quality of both investigational and licensed products manufactured at or under the responsibility of CSL Behring AG, Bern.Background education and experienceDegree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) or medicine or comparable education; advanced degree preferred.12 years' experience working with GMPs across the pharmaceutical industry including leadership/team management experience. Operations or quality oversight experience in sterile product manufacture and filling is preferred.Should meet the CH requirements for the local Responsible Person (Fachtechnisch verantwortliche Person, FvP)Direct experience interacting with global regulatory authorities.Change agent with demonstrated record of success in achieving quality objectives.Demonstrated success in project management and business/QA system.Experience managing within a global matrix organization.Advanced knowledge of appropriate regulatory requirements including GMP/GDP. Prior experience working with plasma derived products and their specific regulations preferred.Fluent in English and German Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
As a Senior Scientific Expert QASF, you will be performing routine and non-routine quality oversight activities in collaboration with the local Maintenance & Utilities, Quality Control, local warehousing, and internal transports teams. You will also be performing Quality on the Floor activities for the areas of responsibility. This includes operational quality management according to cGMP to assure appropriate quality of the services provided to the Value Streams, adherence to CSL standards and procedures, review, and approval of related complex GxP records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, change controls, while keeping awareness of the corresponding quality performance metrics. You will also be expected to participate in cross-functional projects. As a Senior Scientific Expert, you will be a Subject Matter Expert for deviations and changes during inspections and audits.Your responsibilities, in detail, will include:Partnering and influencing relevant stakeholders in maintenance, utilities engineering, quality control and local warehouse to maintain compliance and adhere to QA standards.Provide Quality Assurance oversight and facilitate quality decisions jointly with the stakeholders in the areas of maintenance / utilities, utility monitoring, material management, warehousing, and quality control to maintain compliance in the specified areas.Periodic quality oversight floor tours in warehouse with warehouse supervisor and Supply Chain for improvement and exception handling. Support introduction of new Quality on the Floor activitiesManagement of complex and cross-functional local deviations, isolating GMP-relevant key indices, performing initial risk assessments, Quality on the Floor oversight of the investigation, generating deviation reports, establishing root cause, and defining CAPAs, QA approval/closing of deviations, effective CAPAs and recurrence investigations support.Expert for cross functional change management, manage complex minor, moderate and cross-functional change requests, QASF assessment of changes.Review and completion of APR/PQR regarding raw material data. Review for trending and clusters for rejected lots.Review and approve GxP documentation, including complex documents e.g. QA representative in team risk analyses.Prepare and present quality investigations for minor and major deviations and minor and moderate changes to health authorities.Qualifications and experience required for the position:Master or Graduate university degree in relevant discipline (or equivalent)3+ years of experience working in a similar role.Sound expertise in cGMP and compliance.Material management and warehousing & logistics.Quality control & analytical methods.Experience in change control, deviation management, CAPA management.Strong communication, collaboration and influencing skillsFluent German and English Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
