AVP, External Quality
Merck
August 25, 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 compliant manufacturing/testing/packaging/release.
- Drive timely product release (or coordinate release) for externally manufactured materials.
- Lead major external manufacturing quality investigations (fact finding, root cause, regulatory notifications, recall coordination).
- Provide quality leadership for technology transfers, product launches, pre-approval inspections, and other critical milestones.
- Strengthen partner readiness via strategic support, technical guidance, and engagement with partner leadership.
- Review audit/inspection outcomes and ensure effective CAPA implementation.
- Oversee complaint review and quality issue escalation for externally manufactured products.
- Define performance metrics/governance routines; chair quality performance reviews with partners.
- Lead due diligence for prospective partners; ensure remediation and oversight.
- Establish/maintain Quality Agreements and consult on commercial agreements.
- Establish/chair the External Manufacturing Quality Council and communicate risks to senior leadership.
Education:
- Bachelor’s degree in a scientific discipline required; Advanced degree preferred.
Required Experience/Skills:
- 10+ years in Quality Systems/QA/QC within pharmaceutical manufacturing under global GMP and health authority requirements.
- Experience leading oversight of third-party manufacturers (FDA/cGMP and global regulatory settings).
- Experience with complex investigations, risk assessment, and data-driven decisions.
- Strong compliance background supporting inspections and health authority interactions.
- Experience across quality operations (labs, batch release, QA, quality systems).
- Experience leading large global matrix teams.
- Biologics/vaccines manufacturing experience across multiple nodes; technology transfers, launches, pre-approval inspections, facility start-up.
- Travel ~30%.
Preferred Technical/Functional Skills:
- Advanced degree; experience leading external manufacturing quality networks across biologics and vaccines.
- Expertise in quality governance/supplier oversight/risk-based quality management; familiarity with FDA/EMA/TGA/ANVISA.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline shown on posting; job posting effective until day before end date (08/29/2026).
- 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 compliant manufacturing/testing/packaging/release.
- Drive timely product release (or coordinate release) for externally manufactured materials.
- Lead major external manufacturing quality investigations (fact finding, root cause, regulatory notifications, recall coordination).
- Provide quality leadership for technology transfers, product launches, pre-approval inspections, and other critical milestones.
- Strengthen partner readiness via strategic support, technical guidance, and engagement with partner leadership.
- Review audit/inspection outcomes and ensure effective CAPA implementation.
- Oversee complaint review and quality issue escalation for externally manufactured products.
- Define performance metrics/governance routines; chair quality performance reviews with partners.
- Lead due diligence for prospective partners; ensure remediation and oversight.
- Establish/maintain Quality Agreements and consult on commercial agreements.
- Establish/chair the External Manufacturing Quality Council and communicate risks to senior leadership.
Education:
- Bachelor’s degree in a scientific discipline required; Advanced degree preferred.
Required Experience/Skills:
- 10+ years in Quality Systems/QA/QC within pharmaceutical manufacturing under global GMP and health authority requirements.
- Experience leading oversight of third-party manufacturers (FDA/cGMP and global regulatory settings).
- Experience with complex investigations, risk assessment, and data-driven decisions.
- Strong compliance background supporting inspections and health authority interactions.
- Experience across quality operations (labs, batch release, QA, quality systems).
- Experience leading large global matrix teams.
- Biologics/vaccines manufacturing experience across multiple nodes; technology transfers, launches, pre-approval inspections, facility start-up.
- Travel ~30%.
Preferred Technical/Functional Skills:
- Advanced degree; experience leading external manufacturing quality networks across biologics and vaccines.
- Expertise in quality governance/supplier oversight/risk-based quality management; familiarity with FDA/EMA/TGA/ANVISA.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline shown on posting; job posting effective until day before end date (08/29/2026).