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Seattle Genetics Principal Product Quality Leader in Bothell, Washington

Seattle Genetics Global Quality ยท Bothell, Washington|US Field BasedDescriptionSummary:The Principal Product Quality Leader provides technical expertise and product leadership to the Quality organization. As a product expert in Quality, the Principal Product Quality Leader is responsible for connecting all quality functions for early phase programs and represents the voice of Quality on CMC team. Additionally, this position is responsible for overseeing the Product Quality Review (PQR) business process. Principal Responsibilities: *Quality single point of contact in the CMC team *Responsible for overseeing and maintaining the PQR businessprocess *Lead the creation of product specific quality strategy by working across Quality, Process Sciences and CMC Regulatory groups *Co-Lead the Process, Analytical and Quality workgroup 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 areimplemented *Responsible for developing a phase appropriate productspecification *Author, review, and own the PQ risk register: identify, communicate, elevate, and document acceptance ofrisk *Stay abreast of changes in regulatory standards and expectations as pertaining to productquality *Author and review CMC regulatory dossier sections and information requests (IND, IMPD). *Advance operational excellence within Product Quality Required Qualifications: *Technical aptitude and experience in therapeutic drug development, analytical or formulation development or product characterization *Strong project management experience including generating project plans, timelines and projectdashboards *Skilled at guidingtechnically-orientedbusiness objectives within the framework of regulatory guidance and company quality systems, internally and externally, to achieve value-addingoutcomes *Has a bias for action and displays a sense ofurgency.Must possess strong skills in leadership andcommunication *Demonstrated ability to work cross-functionally and to develop and maintain strong business partnerrelationships *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 matrixedenvironment Preferred Qualifications: *14+years experiencein pharmaceuticals, biologics, or biopharmaceuticals, with experience in a quality related role or a product development role. Previous experience with Annual Product Quality Review (APQR) is a plus *BS or equivalent in Chemistry, Biology, or a similar life science. Advanced degree is aplus As the leading employer in our industry in the Pacific Northwest, 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. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status prote