Lead Quality Assurance Director for Pharmaceutical Operations
vor 19 Stunden
We are seeking an experienced Director of Quality Assurance and Supply Chain Management to join our team at Biogen Idec. As a key member of our commercial release team, you will be responsible for ensuring the continuous supply of compliant medicinal products to approved markets.
About the Role:- Manage the commercial release team and delegate RP release responsibilities
- Ensure complete and timely EU/US product release packages are forwarded to qualified personnel for certification
- Influence manufacturing strategy at CMOs to sustain supply chain integrity
This role requires strong leadership skills, technical knowledge, and experience in managing cross-functional teams. You will also have the opportunity to contribute to technology transfer and improvement projects, as well as actively participate in Health Authority inspections on site.
Key Responsibilities:- Develop and implement quality management systems to ensure compliance with cGMP requirements, EU/FDA regulations, and serialization/data integrity standards
- Collaborate with stakeholders to identify and address compliance gaps in Biogen processes
- Support local quality systems, including change control, deviations, CAPAs, and other quality-related activities
In addition to your technical expertise, we are looking for someone who is passionate about quality and continuous improvement, and who can develop effective working relationships with internal and external sites.
Requirements:- Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology, Biochemistry)
- Minimum 10 years of experience in pharmaceutical or biotechnology industries
- Sound knowledge of cGMP requirements, EU/FDA regulations, and compliance
Salary: $140,000 - $160,000 per year, depending on experience. Benefits include comprehensive health insurance, retirement plan, and generous paid time off.
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