Associate Director, Quality Assurance

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.

• Bachelor’s degree in an appropriate Science, IT, or Engineering discipline.

• 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.

• Experience with Pristima, electronic laboratory notebooks, Veeva, LIMS, Empower.
• Experience leading/supporting US/EU health authority inspections.
• Superior collaboration.

• Audit Management, Collaborative Leadership, Project Leadership, Quality Assurance Systems, Quality Oversight, Regulatory Compliance

• Medical/dental/vision insurance, retirement (401(k)), paid holidays/vacation, compassionate and sick days.