Director, Quality Management Systems/Validation & Compliance Lead
Pfizer
August 31, 2026
Remote friendly (Bothell, WA)
United States
Operations
Role Responsibilities:
- Drive GWE R&D Compliance Program and Systems globally; assure adherence and continuous improvement.
- Ensure compliance for site facility cGLP/cGCP/cGMP and other non-EHS compliance systems; assure compliance with corporate policies.
- Lead design/deployment/training and continuous improvement of global compliance program elements; manage compliance functions (validation, documentation, training).
- Oversee document management strategy; develop/manage/report progress against the Compliance Program (implementation, gap closure).
- Plan/lead management system audits; prepare review reports; drive corrective actions and quality review closure.
- Develop area documentation; ensure consistent compliance across functions; complement PRD/ORD programs.
- Monitor program effectiveness and drive changes; lead certification/registration efforts.
- Serve as global interpretation/maintenance point of contact; facilitate SME meetings and annual compliance objectives.
- Conduct Site Risk Management Reviews; issue/maintain/control site compliance procedures and documents.
- Prepare status reports/presentations; liaise with third-party assessors; manage compliance-related correspondence.
Qualifications:
- Bachelor’s degree in relevant discipline + 8+ years relevant experience.
Preferred:
- Master’s degree; 15+ years in facility management/engineering/compliance in pharma.
- Strong interpersonal, financial/analytical, leadership, influence, facilitation, and global communication skills.
- Ability to translate customer needs, ensure business continuity, develop strategy, advise senior leaders, and develop/train staff.
Minimum Knowledge:
- Facilities Management marketplace (hard/soft services); proven financial management; senior-level track record; quality systems (e.g., ISO 9000, Malcolm Baldrige; Six Sigma a plus); thorough GLP/GCP/GMP knowledge; manage multi-disciplinary teams.
Compensation/Benefits (as stated):
- Base salary range: $162,900–$271,500; bonus target 20%; eligibility for long-term incentive.
- 401(k) with matching + additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision; relocation may be available.
Application Instructions:
- Last date to apply: 9/7/2026.
- Drive GWE R&D Compliance Program and Systems globally; assure adherence and continuous improvement.
- Ensure compliance for site facility cGLP/cGCP/cGMP and other non-EHS compliance systems; assure compliance with corporate policies.
- Lead design/deployment/training and continuous improvement of global compliance program elements; manage compliance functions (validation, documentation, training).
- Oversee document management strategy; develop/manage/report progress against the Compliance Program (implementation, gap closure).
- Plan/lead management system audits; prepare review reports; drive corrective actions and quality review closure.
- Develop area documentation; ensure consistent compliance across functions; complement PRD/ORD programs.
- Monitor program effectiveness and drive changes; lead certification/registration efforts.
- Serve as global interpretation/maintenance point of contact; facilitate SME meetings and annual compliance objectives.
- Conduct Site Risk Management Reviews; issue/maintain/control site compliance procedures and documents.
- Prepare status reports/presentations; liaise with third-party assessors; manage compliance-related correspondence.
Qualifications:
- Bachelor’s degree in relevant discipline + 8+ years relevant experience.
Preferred:
- Master’s degree; 15+ years in facility management/engineering/compliance in pharma.
- Strong interpersonal, financial/analytical, leadership, influence, facilitation, and global communication skills.
- Ability to translate customer needs, ensure business continuity, develop strategy, advise senior leaders, and develop/train staff.
Minimum Knowledge:
- Facilities Management marketplace (hard/soft services); proven financial management; senior-level track record; quality systems (e.g., ISO 9000, Malcolm Baldrige; Six Sigma a plus); thorough GLP/GCP/GMP knowledge; manage multi-disciplinary teams.
Compensation/Benefits (as stated):
- Base salary range: $162,900–$271,500; bonus target 20%; eligibility for long-term incentive.
- 401(k) with matching + additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision; relocation may be available.
Application Instructions:
- Last date to apply: 9/7/2026.