This position will provide quality oversight in the implementation and maintenance of validated computerized systems. Perform review and approval of change requests, validation documentation, periodic reviews of validated systems, and/or procedures, as assigned. May coordinate one or more quality system (change management, validation program) and/or develop validation schedules. The position will collaborate as a quality expert on multiple cross-functional project teams and will be accountable for ensuring validation deliverables are technically sound and aligned with company, industry, and regulatory expectations.
* Coordinate one or more systems under the responsibility of the SVAL group from the following:
* Computerized system validation
* Change management
* Periodic review of validated systems
* Work with system owners and support departments to deliver new systems, and system changes to operational release.
* Review/collaborate and/or approve SOPs, validation plans, protocols, and/or reports, as required.
* May coordinate or participate in Change Review Board (CRB) meetings
* Develop validation plans (VMPs), validation schedules, and summary reports.
* Review and approve validation deliverables for compliance with Seattle Genetics policies and procedures.
* Provide validation support for internal and external GMP audits, as required. Travel may be required for supplier audits.
* Participate in GMP regulatory and QP inspections.
* Support review and approval of deviations/incident handling to assess impact on validation, as needed.
* Other duties as assigned
* Working knowledge of applicable regulations (cGMP, GLP, GCP), including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
* Prior Quality Assurance experience
* Bachelor's degree and 3+ years of relevant quality assurance, manufacturing or quality control experience in the biotech or pharmaceutical industry; or 5+ years of relevant quality assurance, manufacturing or quality control experience in the biotech or pharmaceutical industry
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics 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 protected by federal, state, or local law.
About Seattle Genetics
Seattle Genetics is dedicated to improving patient outcomes through advanced antibody-drug conjugate technology designed to deliver cell-killing agents directly to tumor cells.