Quality Assurance Manager
vor 1 Monat
Job Description
About the Role:
Location: Baar, Switzerland
In this position, you will serve as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), in accordance with the Swiss Medicinal Products Licensing Ordinance (MPLO), and the Swissmedic Technical Interpretation I-SMI.TI.17, within Biogen Switzerland AG. The RP/FvP acts as the primary liaison for Quality Assurance (QA) matters with distributors and external entities, ensuring the quality of distributed medicinal products (GMP/GDP). You will supervise quality assurance and support GxP activities at Biogen Affiliates and Distribution partners, ensuring product quality throughout the distribution chain. This includes managing new product launches and addressing product-related issues in collaboration with various functional areas.Responsibilities:
As the Deputy RP/FvP for Biogen Switzerland AG:
You will have the authority to issue directives and make decisions regarding your responsibilities, independently from Biogen Management and the Swiss Affiliate Leadership Team. Ensure compliance with all National and International Regulations (e.g., MPLO, Cantonal Laws) and internal policies, focusing on the management of authorized activities and the accuracy of records. Guarantee that all medicinal products are managed correctly, particularly in relation to product specifications, testing instructions, storage conditions, expiry dates, and quality standards.In your capacity as Deputy RP/FvP:
You will independently decide on the final release of batches to the Swiss market, in accordance with local legislation. Manage, document, and report product returns, including decisions on reintegration into saleable stock. Make independent decisions regarding the disposition of rejected, recalled, falsified, and expired products. Oversee Product Quality Review (PQR/AQP) Assessments as per applicable SOPs and local laws. Ensure readiness for inspections related to Operational License activities, such as import and wholesale operations. Ensure timely renewal and updates of Operational Licenses per the Swissmedic License Application Process. Stay informed on GMP/GDP and evolving Regulatory requirements, ensuring the appropriateness of licenses and distribution models. Ensure that suppliers and customers are approved in coordination with relevant departments. Approve any subcontracted activities that may impact GMP/GDP regulations and oversee their qualification and monitoring. Develop and maintain local Quality Agreements. Ensure compliance with any additional requirements imposed by local Regulatory Bodies. Develop and maintain local procedures in alignment with local regulations and Global QMS. Manage a locally initiated and ongoing training program, including GxP training. Oversee and approve local quality records (deviations, CAPAs, Change Controls) and assist with other quality-related tasks. Host local Health Authority inspections and Internal Affiliate Audits, ensuring readiness and follow-up. Lead and coordinate the local Self-Inspection program, including risk assessments. Review internal audit reports, including CAPAs, of Manufacturers, CMOs, CROs, and Service Providers involved in the manufacturing and distribution of medicinal products. Ensure Technical Product Complaints (TPCs) are managed according to local and Global procedures. Ensure customer complaints are addressed effectively. Coordinate recalls in collaboration with local and global Recall Committees, ensuring proper documentation and follow-up. Manage temperature excursion assessments and determine the usability of affected products. Collaborate with necessary departments to ensure appropriate communication with Health Authorities.As Manager, Quality Assurance:
Ensure compliance with required regulations at each Affiliate site to maintain appropriate distribution licenses. Coordinate activities to establish applicable licenses and liaise with all functional areas to meet license requirements. Promote Quality understanding at Affiliate management by providing QA operational support and guidance. Manage the Quality System for Affiliates to ensure compliance with Biogen and applicable GxP regulations. Ensure Affiliate QMS aligns with Biogen Global QMS. Manage the Quality Management Review process for Affiliates. Oversee the Affiliate GxP vendor management program. Support Affiliate audits and Health Authority Inspections. Assist in drafting and reviewing GxP-related documents. Approve exceptional in-country repackaging activities. Develop and maintain Quality Agreements with external partners. Assess the regulatory environment to identify GxP requirements impacting the supply chain. Ensure continuous product supply and support product launches. Support Distribution Model changes and product serialization. Monitor market activities and escalate issues to the appropriate responsible parties. Minimize out-of-stock situations in coordination with other functions.Who You Are:
You possess fluency in both German and English. You demonstrate a high level of integrity and a strong sense of business partnership. You have the ability to understand complex processes and maintain an overview in challenging situations. You are action-oriented, methodical, and consistently work towards achieving set goals. You exhibit strong conceptual, strategic, and analytical skills, and are adept at working in cross-functional teams. You have good intercultural awareness and can prioritize multiple tasks effectively. You also have sound training experience, including material development and training delivery.
Qualifications:
Higher education in pharmaceutical or natural sciences, with a minimum of a Master's degree, preferably a PhD or Pharmacist. Knowledge of Swissmedic Technical Interpretation I-SMI.TI.17. At least 5 years of experience in the pharmaceutical or related industry in QA/RA. Proven track record in QA, including registrations, audits, and inspections. Proficiency in English and German (speaking and writing). Commitment to continuous learning. Familiarity with Biogen procedural documents and International Guidelines such as ICH/GCP. Strong understanding of GMP and GDP regulations and certification processes. Excellent project management skills. Proficient in PC applications (Word, Excel, PowerPoint) and specialized software.Additional Information:
Why Biogen?
We are a global team dedicated to excellence and innovation. As a mid-sized biotechnology company, we offer the stability and resources of an established business while fostering an environment where individual contributions are valued. Our team comprises talented and passionate individuals who have unparalleled opportunities for growth and skill development. Together, we strive to deliver life-changing medicines, with every role playing a vital part in our mission. We are committed to building a culture of inclusion and belonging that reflects the communities we serve. We recognize that diverse backgrounds and perspectives make us stronger and more innovative, and we are focused on creating teams where every employee feels empowered and inspired.
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