Manager, External Quality Operations

Vor 6 Tagen

Zug, Schweiz Seagen Vollzeit

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us

Summary:
**Responsibilities**:

- 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
- Fluency in spoken and written English
- Ability to travel within Europe and APAC (up to 40%) as well as occasional travel to the Corporate HQ in the US#LI-LO1

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