Associate Quality Assurance External Operations

vor 15 Stunden

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:
This position will support the manufacturing and testing of clinical and commercial GMP materials with a focus on batch/lot review. The role reports into the Associate Director of European Quality Operations. The role sits within a growing Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.

Principal Responsibilities:

- Manage lot review activities for clinical, late phase and commercial GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are met
- Review and manage deviations from contractors related to manufacturing and testing
- Coordinate release activities with the other team members
- Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP expectations. Communicate and resolve discrepancies with CMO’s
- Compile and manage lot files
- Enter data in to process monitoring system draft PQR sections
- Perform activities connected with the CMO independent Batch Record Review certification program
- Participate in quality system improvements.
- Author and/or revise standard operating procedures and associated work instructions
- Interface diligently with local and global teams to ensure efficient and effective communication on project status and issues

Qualifications:

- 3+ years’ experience in the regulated pharmaceutical industry, with 1-2 years in QA or manufacturing.
- Strong knowledge and experience with US/EU GMPs, ICH and other applicable international regulations
- Experience with the production and testing of pharmaceuticals (biologic or small molecules)
- Experience working with contract givers preferred
- Excellent communication skills and proven ability to work well with internal and external teams
- Experience with electronic documentation management systems preferred
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
- Fluency in English is a must
- thorough understanding of local compliance, as well as a sound ethical approach to business

**Education**:

- Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.)

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