Director, Quality Management Systems/Validation & Compliance Lead
Pfizer
August 31, 2026
On-site
Pearl River, NY
Operations
Role Responsibilities
- Assure compliance for site facility cGLP, cGCP, cGMP and other non-EHS compliance systems/activities.
- Own and drive GWE R&D Compliance Program design, deployment, training, and continuous improvement globally.
- Manage compliance functions (e.g., validation, documentation, training) supporting cGLPs/cGCPs/cGMPs and other non-EHS regulations.
- Oversee adherence to GWE R&D document management; develop/manage/report progress on compliance implementation, gap closure, and strategy.
- Lead management system audits; identify corrective actions; verify CAPA effectiveness and drive quality review corrective action completion.
- Engage stakeholders (colleagues, partners, vendors, customers) to develop the compliance program; ensure consistent application and alignment with PRD/ORD programs.
- Monitor compliance effectiveness and implement changes based on efficiencies/business needs.
- Lead area certification/registration efforts; facilitate SME meetings and define short/long-term strategies.
- Serve as global interpretation/maintenance contact for functional elements; conduct site risk management reviews.
- Issue/maintain site-level compliance procedures and provide guidance to functional representatives.
- Prepare status reports/presentations for site/GWE R&D leaders; liaise with third-party assessors.
Basic Qualifications
- Bachelor’s degree in relevant discipline + 8+ years relevant experience.
Preferred Qualifications / Required Skills (high level)
- Master’s degree; 15+ years in facility management/engineering/compliance in pharma.
- Strong financial/analytical skills, senior stakeholder influence, and consensus facilitation.
- Proven implementation/maintenance of quality systems (e.g., ISO 9000, Malcolm Baldrige; Six Sigma a plus).
- Thorough GLP/GCP/GMP knowledge; experience managing multi-disciplinary teams.
Benefits / Compensation (as stated)
- Base salary: $162,900–$271,500; bonus target 20%; 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision.
Application Instructions
- Last date to apply: 9/7/2026.
- Assure compliance for site facility cGLP, cGCP, cGMP and other non-EHS compliance systems/activities.
- Own and drive GWE R&D Compliance Program design, deployment, training, and continuous improvement globally.
- Manage compliance functions (e.g., validation, documentation, training) supporting cGLPs/cGCPs/cGMPs and other non-EHS regulations.
- Oversee adherence to GWE R&D document management; develop/manage/report progress on compliance implementation, gap closure, and strategy.
- Lead management system audits; identify corrective actions; verify CAPA effectiveness and drive quality review corrective action completion.
- Engage stakeholders (colleagues, partners, vendors, customers) to develop the compliance program; ensure consistent application and alignment with PRD/ORD programs.
- Monitor compliance effectiveness and implement changes based on efficiencies/business needs.
- Lead area certification/registration efforts; facilitate SME meetings and define short/long-term strategies.
- Serve as global interpretation/maintenance contact for functional elements; conduct site risk management reviews.
- Issue/maintain site-level compliance procedures and provide guidance to functional representatives.
- Prepare status reports/presentations for site/GWE R&D leaders; liaise with third-party assessors.
Basic Qualifications
- Bachelor’s degree in relevant discipline + 8+ years relevant experience.
Preferred Qualifications / Required Skills (high level)
- Master’s degree; 15+ years in facility management/engineering/compliance in pharma.
- Strong financial/analytical skills, senior stakeholder influence, and consensus facilitation.
- Proven implementation/maintenance of quality systems (e.g., ISO 9000, Malcolm Baldrige; Six Sigma a plus).
- Thorough GLP/GCP/GMP knowledge; experience managing multi-disciplinary teams.
Benefits / Compensation (as stated)
- Base salary: $162,900–$271,500; bonus target 20%; 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision.
Application Instructions
- Last date to apply: 9/7/2026.