Seagen

Quality Assurance Manager - External Supply Operations

Summary:

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

Qualifications:

• 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

Seagen is an Equal Opportunity Employer

Submitted: 12/18/2020