Senior Quality Assurance Manager
vor 21 Stunden
At Biogen, we are seeking a seasoned Senior Quality Assurance Manager to join our team in Baar, Switzerland.
About the RoleWe are looking for an experienced professional with a strong background in quality assurance and regulatory compliance. The successful candidate will be responsible for ensuring that our products meet the highest standards of quality and safety.
In this role, you will oversee quality assurance and support GxP activities at Biogen Affiliates and Distribution partners to ensure product quality all the way to patient.
- You will ensure control of the distribution chain to maintain quality and integrity of medicinal products, new product launches, and product-related issues in cooperation with different functional areas.
- You will have the authority to issue directives and take decisions with regards to your responsibilities, independently of Biogen Management and the Swiss Affiliate Leadership Team.
Key Responsibilities:
- Ensure Quality Assurance related compliance with all National and International Regulations (e.g., MPLO, Cantonal Laws and Regulations, etc.) and internal regulations.
- Manage Product Quality Review (PQR/AQP) Assessments as per applicable SOPs and local law.
- Ensure timely renewal and update, if applicable, of Operational Licenses per Swissmedic License Application Process.
- Knowledgeable on GMP/GDP and changing Regulatory requirements and ensure appropriateness of licenses and distribution models to distribute medicinal products.
The ideal candidate will have a higher education in pharmaceutical or natural sciences, minimum of Master Level, preferably PhD or Pharmacist.
They should have at least 5 years' experience in pharmaceutical or related industry in the field of QA/RA, track record in the field of QA including registrations, audits & inspections.
Fluent in English and German (speaking & writing) is required, along with willingness to continuously learn and good knowledge of Biogen procedural documents, International Guidelines such as ICH/GCP, etc.
We offer a competitive salary of €80,000 - €100,000 per year, depending on experience, and a comprehensive benefits package.
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