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Quality Assurance Manager External Supply Operations
View: 166
Update day: 26-03-2024
Category: Quality Assurance / Quality Control
Industry: Research Biotechnology Pharmaceuticals
Position: Mid-Senior level
Job type: Full-time
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Job content
SummaryDescription
The Quality Assurance Manager, External Supply Operations, Europe, based in Zug, Switzerland, will act as a point of contact and subject matter expert for all quality related activities at contract manufacturers (CMOs) of API and Drug Product in Europe.
Responsibilities
- Serve as the point of contact and subject matter expert for all quality related activities at contract manufacturers (CMOs) of Intermediates, API and Drug Product in Europe
- Develop, monitor, and maintain positive relationships with CMOs and partners to encourage collaboration, improvements, transparency, and accountability
- Perform batch review activities ensuring products are dispositioned in accordance with company policies, international regulations, and quality agreements
- Coordinate cross-functional activities between the CMOs, partners, and stakeholders to enable efficient disposition of batches per schedule
- Manage and review deviations and changes per Seagen procedures and Quality Agreements
- Oversee and facilitate validation activities at the CMO sites
- Review cGMP Master Controlled Documents such as batch production records, specifications, and test methods for accuracy, compliance to procedures and regulatory requirements
- Develop and maintain Quality Agreements
- Collaborate with CMOs and corporate HQ on performance metrics, process monitoring, and product quality reviews
- Collaborate with manufacturing sites on preparation for health authority inspections and provides on-site support during inspections as needed
- Demonstrate effectiveness in task completion, decision-making, problem solving, communication, and collaboration
- Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.) - 8+ years experience in the regulated pharmaceutical industry, with 3+ years in QA.
- Practical experience in pharmaceutical manufacturing and testing, with extensive knowledge of validation practices, GMPs and other applicable international regulations
- Experience with both small and large molecules preferred
- Experience working with CMOs
- Excellent communication skills and proven ability to work well with internal and external teams. Experience with virtual teams or multi-site organizations preferred
- Strong commitment to the accomplishment of tasks, adherence to procedures, and the initiative to identify opportunities for improvements
- Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving
- Fluency in spoken and written English
- Ability to travel within Europe (up to 40%) as well as occasional travel to the Corporate HQ in the US
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.
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Deadline: 10-05-2024
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