Associate Director, Quality Assurance
Merck
August 25, 2026
Remote friendly (West Point, PA)
United States
Operations
Primary Responsibilities:
- Facilitate communication and alignment with key stakeholders.
- Execute and close global GLP QA audit activities (domestic/international sites and contract facilities) and ensure compliance with FDA GLP/OECD guidance, company policies, procedures, and QA SOPs.
- Conduct GLP and regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits using QA risk-based processes.
- Lead liaison for QA activities supporting regulated work across sites.
- Independently function as a lead auditor; provide regulatory perspective/quality advice.
- Plan, prioritize, schedule, monitor, document/track audits/inspections, ensure timely resolution of findings, and report findings to appropriate personnel.
- Maintain expertise in applicable worldwide regulations; interpret and distribute regulatory guidance as needed.
- Develop and deliver compliance training; mentor less experienced QA staff; participate in committees.
- Manage multiple/moderately complex projects; lead escalation and support CAPA/root-cause assessment.
- Serve as key point person for inspection management; represent GLP QA/QA on cross-functional teams.
Education:
- Bachelor’s degree in an appropriate Science, IT, or Engineering discipline.
Required:
- 8+ years of audit experience in regulated pharma/biopharma/biologics.
- Extensive FDA and OECD GLP knowledge; experience leading audits.
- Leadership; cross-functional teamwork; electronic quality systems experience.
- Strong attention to detail; Microsoft PowerPoint/Excel/Word; excellent written/verbal communication; manage competing priorities.
Preferred:
- Experience with Pristima, electronic laboratory notebooks, Veeva, LIMS, Empower.
- Experience leading/supporting US/EU health authority inspections.
- Superior collaboration.
Skills:
- Audit Management, Collaborative Leadership, Project Leadership, Quality Assurance Systems, Quality Oversight, Regulatory Compliance
Benefits (explicitly stated):
- Medical/dental/vision insurance, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Facilitate communication and alignment with key stakeholders.
- Execute and close global GLP QA audit activities (domestic/international sites and contract facilities) and ensure compliance with FDA GLP/OECD guidance, company policies, procedures, and QA SOPs.
- Conduct GLP and regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits using QA risk-based processes.
- Lead liaison for QA activities supporting regulated work across sites.
- Independently function as a lead auditor; provide regulatory perspective/quality advice.
- Plan, prioritize, schedule, monitor, document/track audits/inspections, ensure timely resolution of findings, and report findings to appropriate personnel.
- Maintain expertise in applicable worldwide regulations; interpret and distribute regulatory guidance as needed.
- Develop and deliver compliance training; mentor less experienced QA staff; participate in committees.
- Manage multiple/moderately complex projects; lead escalation and support CAPA/root-cause assessment.
- Serve as key point person for inspection management; represent GLP QA/QA on cross-functional teams.
Education:
- Bachelor’s degree in an appropriate Science, IT, or Engineering discipline.
Required:
- 8+ years of audit experience in regulated pharma/biopharma/biologics.
- Extensive FDA and OECD GLP knowledge; experience leading audits.
- Leadership; cross-functional teamwork; electronic quality systems experience.
- Strong attention to detail; Microsoft PowerPoint/Excel/Word; excellent written/verbal communication; manage competing priorities.
Preferred:
- Experience with Pristima, electronic laboratory notebooks, Veeva, LIMS, Empower.
- Experience leading/supporting US/EU health authority inspections.
- Superior collaboration.
Skills:
- Audit Management, Collaborative Leadership, Project Leadership, Quality Assurance Systems, Quality Oversight, Regulatory Compliance
Benefits (explicitly stated):
- Medical/dental/vision insurance, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.