Quality Assurance Manager

vor 3 Wochen


Baar, Zug, Schweiz Biogen Vollzeit

About the Role:

Biogen is seeking a seasoned Quality Assurance professional to join our team in Switzerland.

Job Description:

  • Act as Deputy Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) in accordance with the Swiss Medicinal Products Licensing Ordinance (MPLO) and Swissmedic Technical Interpretation I-SMI.TI.17.
  • Ensure quality assurance and support GxP activities at Biogen affiliates and distribution partners to maintain product quality and integrity.
  • Oversee and manage the distribution chain to ensure compliance with regulations and quality standards.
  • Develop and maintain local quality agreements with external partners.
  • Manage and report product returns, including decisions on re-integration to saleable stock.
  • Ensure timely renewal and update of operational licenses per Swissmedic License Application Process.
  • Coordinate activities to establish affiliate applicable licenses and liaise with functional areas to meet license requirements.
  • Manage quality system for affiliates to ensure compliance with Biogen Global QMS.
  • Ensure affiliate QMS complies with global QMS.
  • Host local health authority inspections and internal affiliate audits.
  • Lead and develop local self-inspection programs.
  • Review and evaluate internal audit reports, including CAPAs.
  • Ensure technical product complaints are handled according to local and global procedures.
  • Execute recalls in collaboration with local and global recall committees.

About You:

We are looking for a highly skilled and experienced Quality Assurance professional with a strong background in pharmaceutical or related industries.

Qualifications:

  • Higher education in pharmaceutical or natural sciences (minimum Master's level, preferably PhD or Pharmacist).
  • Swissmedic Technical Interpretation I-SMI.TI.17.
  • At least 5 years' experience in pharmaceutical or related industries in QA/RA.
  • Track record in QA including registrations, audits, and inspections.
  • Fluent in English and German (speaking and writing).
  • Willingness to continuously learn.
  • Good knowledge of Biogen procedural documents, international guidelines, and regulations in GMP and GDP.


  • Baar, Zug, Schweiz Biogen Vollzeit

    Biogen Switzerland AG is seeking a Quality Assurance Deputy Manager to join our team. Our ideal candidate will have a higher education in pharmaceutical or natural sciences and a minimum of 5 years of experience in pharmaceutical or related industry in the field of QA/RA. The Deputy Responsible Person and Quality Assurance Manager will be responsible for...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About the Role:This is a challenging opportunity to join Biogen as a Quality Assurance Manager, where you will play a key role in ensuring the quality of our medicinal products. As the Deputy Responsible Person, you will be responsible for ensuring compliance with all national and international regulations, including GMP and GDP.Key Responsibilities:Ensure...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About the Role:The Quality Assurance Specialist will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our operations. This includes overseeing quality assurance and support GxP activities at Biogen Affiliates and Distribution partners to ensure product quality all the way to patient.Key...


  • Baar, Zug, Schweiz Biogen Vollzeit

    Job DescriptionAbout the Role:Location: Baar, SwitzerlandIn this role, you will act as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), according to the Swiss Medicinal Products Licensing Ordinance (MPLO), SR 812.212.1, Arts., 12, 13, 17, 18 and the Swissmedic Technical Interpretation I-SMI.TI.17, within Biogen...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About the Role:Location: Baar, SwitzerlandIn this role, you will act as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), according to the Swiss Medicinal Products Licensing Ordinance (MPLO), SR 812.212.1, Arts., 12, 13, 17, 18 and the Swissmedic Technical Interpretation I-SMI.TI.17, within Biogen Switzerland AG (Swiss...


  • Baar, Zug, Schweiz Medela Vollzeit

    Quality Assurance SpecialistMedela is seeking a Quality Assurance Specialist to join our team.Key Responsibilities:Support the quality function with document control, reviewing and archival of documents.Update of quality records in their respective storage locations.Support change management activities through initiation of change controls and maintenance of...


  • Baar, Zug, Schweiz Medela Vollzeit

    At Medela, we are seeking a Quality Assurance Specialist to support our "Essentials" product portfolio related to all quality aspects and our quality management system. The ideal candidate will have a strong background in quality assurance and a passion for driving process improvements.Key responsibilities include:Supporting the quality function with...


  • Baar, Zug, Schweiz Medela Vollzeit

    You are a key member of our team at Medela, responsible for driving the implementation and improvement of quality processes. Your goal is to ensure the delivery of high-quality products to our customers.You will work closely with internal stakeholders, customers, and suppliers to support document control, reviewing, and archival of documents. You will also...


  • Baar, Zug, Schweiz Medela Vollzeit

    As a Quality Assurance Specialist at Medela, you will play a crucial role in supporting our "Essentials" product portfolio related to all quality aspects and our quality management system. Your goal will be to continuously drive the implementation and improvement of processes and to verify manufacturing processes. You will work with internal stakeholders,...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About the Role:We are seeking a highly skilled Quality Assurance Deputy to join our team at Biogen Switzerland AG. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our medicinal products.Responsibilities:Act as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche...


  • Baar, Zug, Schweiz Medela Vollzeit

    Job Description:As a Quality Assurance Professional at Medela, you will play a crucial role in ensuring the delivery of high-quality products to our customers. Your primary responsibility will be to drive the implementation and improvement of quality processes and to verify manufacturing processes.You will work closely with internal stakeholders, customers,...


  • Baar, Zug, Schweiz Medela Vollzeit

    You are supporting our "Essentials" product portfolio related to all quality aspects and our quality management system. It is your goal to continuously drive the implementation and improvement of processes and to verify manufacturing processes.Key ResponsibilitiesSupport the quality function with document control, reviewing and archival of documentsUpdate of...


  • Baar, Zug, Schweiz Global Message Services Vollzeit

    About the Role:GMS is a leading provider of AI-driven communications solutions, partnering with Mobile Network Operators and enterprises globally. As a Manual Tester, you will play a crucial role in ensuring the quality of our software products.Key Responsibilities:Review and analyze system specifications to identify potential issues.Develop and execute test...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    Job SummaryBiogen Idec is seeking a highly skilled and experienced Senior Quality Release Manager to lead the commercial release team and ensure the continuous supply of compliant medicinal products to approved markets. The successful candidate will be responsible for managing the release process, ensuring compliance with regulatory requirements, and...

  • Senior Release Manager

    vor 4 Wochen


    Baar, Zug, Schweiz Biogen Idec Vollzeit

    About This RoleAs a Senior Release Manager at Biogen, you will be responsible for leading the commercial release team to ensure continuous supply of compliant Medicinal Products to approved markets. You will also act as a Responsible Person (RP) delegate for Active Pharmaceutical Ingredients (API), Drug Substances (DS), and Drug Products (DP) technical...

  • Young IT Manager

    vor 4 Wochen


    Baar, Zug, Schweiz Bodum AG Vollzeit

    Job Overview:We are seeking a highly skilled IT Manager to lead our international IT teams and oversee IT initiatives at Bodum AG. This role offers an exciting opportunity to provide technical support, promote collaboration, and drive innovation across our diverse locations.Key Responsibilities:Team Leadership:Direct and manage IT team members to achieve...

  • IT Project Manager

    vor 4 Wochen


    Baar, Zug, Schweiz AMAN Vollzeit

    Job Title: IT Project Manager - Strategic LeaderJob Summary: We are seeking an experienced IT Project Manager to lead our projects and teams to success.Key Responsibilities:* Prepare project plans and specifications from technical requirements* Liaise with internal and external partners, vendors, and resources* Monitor daily progress and provide timely...


  • Baar, Zug, Schweiz Medela Vollzeit

    Job SummaryAs a key member of our Operations team, you will be responsible for managing a wide range of projects and change activities. This role requires strong business acumen, negotiation skills, and the ability to work effectively with our R&D department and external suppliers.Key ResponsibilitiesManage operational projects, including changes in...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    Job Summary: Biogen seeks a highly experienced Senior Pharmaceutical Release Manager to lead the commercial release team and ensure compliant Medicinal Product supply to approved markets. This role is ideal for individuals with a strong background in the pharmaceutical industry and excellent leadership skills.Responsibilities:Oversee the commercial release...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About This RoleAs the Senior Manager of Supplier Relationship Management for Sourced Materials, you will be responsible for fostering and maintaining strong relationships with vendors and suppliers, ensuring their performance aligns with Biogen's needs. This key role drives the continuous supply of commercialized products to our patients and implements...