AVP, External Quality
Merck
August 19, 2026
Remote friendly (West Point, PA)
United States
Operations
Primary Responsibilities
- Lead strategy, organizational design, budget oversight, and performance management for a global External Manufacturing Quality team (~100 professionals).
- Establish and maintain a risk-based quality oversight framework for ~30 external manufacturing sites (cell banking, drug substance, drug product, packaging, testing, release, storage, distribution).
- Direct quality oversight of external partners to ensure compliance with company requirements and global regulatory expectations.
- Drive timely product release/coordination for external supplier-manufactured materials.
- Lead major investigations (fact finding, root cause, regulatory notifications, recall coordination).
- Provide quality leadership for technology transfers, product launches, pre-approval inspections, and facility start-up.
- Strengthen partner readiness; engage partner leadership teams.
- Ensure audits/inspections corrective and preventive actions are implemented and sustained.
- Oversee complaint review and quality issue escalation.
- Define performance metrics and governance routines; chair quality performance reviews.
- Lead due diligence for prospective partners; ensure remediation.
- Establish/maintain Quality Agreements and advise on commercial agreements.
- Build calibrated quality systems at partner sites; chair the External Manufacturing Quality Council; communicate risks to senior leadership.
Education
- Bachelor’s degree in a scientific discipline required. Advanced degree preferred.
Required Experience And Skills
- 10+ years in Quality Systems/QA/QC in pharmaceutical manufacturing under global GMP/health authority requirements.
- Experience leading third-party manufacturer quality oversight (FDA/cGMP and global regulatory settings).
- Track record managing complex investigations, risk assessment, and data-driven decisions.
- Strong compliance/regulatory inspection experience; significant quality operations leadership.
- Experience leading large global matrixed teams; biologics/vaccines manufacturing across multiple nodes.
- Technology transfers, product launches, pre-approval inspections, and facility start-up experience.
- Travel ~30% (including short-notice).
Preferred Technical/Functional Skills
- Advanced degree; experience leading external manufacturing quality networks for both biologics and vaccines; strong supplier oversight/governance and regulatory agency familiarity (FDA, EMA, TGA, ANVISA).
Benefits
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting’s stated deadline.
- Lead strategy, organizational design, budget oversight, and performance management for a global External Manufacturing Quality team (~100 professionals).
- Establish and maintain a risk-based quality oversight framework for ~30 external manufacturing sites (cell banking, drug substance, drug product, packaging, testing, release, storage, distribution).
- Direct quality oversight of external partners to ensure compliance with company requirements and global regulatory expectations.
- Drive timely product release/coordination for external supplier-manufactured materials.
- Lead major investigations (fact finding, root cause, regulatory notifications, recall coordination).
- Provide quality leadership for technology transfers, product launches, pre-approval inspections, and facility start-up.
- Strengthen partner readiness; engage partner leadership teams.
- Ensure audits/inspections corrective and preventive actions are implemented and sustained.
- Oversee complaint review and quality issue escalation.
- Define performance metrics and governance routines; chair quality performance reviews.
- Lead due diligence for prospective partners; ensure remediation.
- Establish/maintain Quality Agreements and advise on commercial agreements.
- Build calibrated quality systems at partner sites; chair the External Manufacturing Quality Council; communicate risks to senior leadership.
Education
- Bachelor’s degree in a scientific discipline required. Advanced degree preferred.
Required Experience And Skills
- 10+ years in Quality Systems/QA/QC in pharmaceutical manufacturing under global GMP/health authority requirements.
- Experience leading third-party manufacturer quality oversight (FDA/cGMP and global regulatory settings).
- Track record managing complex investigations, risk assessment, and data-driven decisions.
- Strong compliance/regulatory inspection experience; significant quality operations leadership.
- Experience leading large global matrixed teams; biologics/vaccines manufacturing across multiple nodes.
- Technology transfers, product launches, pre-approval inspections, and facility start-up experience.
- Travel ~30% (including short-notice).
Preferred Technical/Functional Skills
- Advanced degree; experience leading external manufacturing quality networks for both biologics and vaccines; strong supplier oversight/governance and regulatory agency familiarity (FDA, EMA, TGA, ANVISA).
Benefits
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting’s stated deadline.