Senior Specialist Computer System Compliance

Global Quality Bothell, Washington


Description

Summary: 

This position will provide quality oversight of 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 Global Quality quality system programs (change management, vendor management, validation oversight).  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.

Principal Responsibilities: 

  • Provide Quality Oversight on validation projects and approve life-cycle documentation for small to large systems to assure systems are fit for purpose in GMP operations
  • Support multiple customer groups and junior staff by resolving complex issues supporting a range of projects
  • Approve and perform impact assessments on system and program change controls
  • Approve system operation, administration and use SOPs
  • Approve and oversee investigations on system deviations and incidents on small to large systems
  • Participate/attend trainings, webinars, and conferences
  • Uses regulatory and industry knowledge to provide Quality oversight of the  IT QMS in harmony with the Quality Unit ensuring processes comply with regulations
  • Keeps up to date with regulations, guidance documents, and industry trends to align program, assure compliance, and maintain department reference library

Required Qualifications:

  • BA/BS in a relevant field with 10+ years relevant GMP and/or validation experience;
  • Strong working knowledge of computerized system validation following industry standards (GAMP), and cGMP is required, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
  • Prior QA experience
  • Prior systems validation experience
  • Previous experience working with change management systems
  • Excellent written and oral communication skills
  • Ability to proactively identify and implement continual improvements
  • Proven ability to work effectively in a fast paced team environment
  • Ability to organize information in a consistent and readily retrievable manner

 Preferred Qualifications:

  • Experience with SaaS, PaaS, and IaaS system implementation in the life sciences industry
  • Involvement with industry groups such as PDA and/or ISPE

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.

#LI-DD1