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Seagen
Senior Manager, Product Quality Leader
Technical Operations & Process Sciences - Amsterdam, Netherlands
Description
Position Summary
The Product Quality Leader serves as a technical quality expert for the product during clinical development all the way through post-commercialization and is responsible for making quality-related decisions and serving as a liaison between the project team and other quality functions. This role is the single point of contact for all quality issues associated with the development of one or more early/late phase programs. This role is a key member of the CMC subteam, providing efficient and effective strategic and quality input into CMC related activities and associated quality decisions.
Principal Responsibilities
- Quality single point of contact in the CMC team.
- Lead the creation of product specific quality strategy by working across Quality, Technical Development, Manufacturing and CMC Regulatory groups.
- Lead Quality Operation team to implement the quality strategy, influence, advice and coordinate strategic and operational efforts across Quality.
- Drive product quality risk management, issue identification, resolution and contingency planning.
- Responsible for establishing a phase appropriate Quality Target Product Profile (QTPP) & accountable for ensuring the right quality characteristics are implemented.
- Responsible for developing a phase appropriate product specifications.
- Author, review, and own the PQ risk register: identify, communicate, elevate, and document acceptance of risk.
- Stay abreast of changes in regulatory standards and expectations as pertaining to product quality.
- Author and review CMC regulatory dossier sections and information requests (IND, IMPD).
- Advance operational excellence within Product Quality./li>
Qualifications
- Requires a minimum of 10+ years experience in pharmaceuticals, biologics, or bio-pharmaceuticals, with experience in a quality related role or a product development role
- 4+ years direct or indirect team management/leadership (i.e. direct reports or matrixed team leadership)
- Technical aptitude and experience in therapeutic drug development, analytical, process or formulation development or product characterization
- Skilled at guiding technically-oriented business objectives within the framework of regulatory guidance and company quality systems, internally and externally, to achieve value-adding outcomes.
- Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership and communication.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment.
- Thorough understanding of local compliance, as well as a sound ethical approach to business.
Education:
- BS or equivalent in Chemistry, Biology, or a similar life science. Advanced degree is a plus.
Competencies:
- Persuades
- Balances Stakeholders
- Manges complexity
- Strategic mindset
- Collaborates
- Communicates effectively
- Manages ambiguity
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 12/09/2022
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