Quality Assurance Manager
vor 3 Wochen
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.
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