QA Specialist V - QA Inspection Audit Management
On-sitePortsmouth, New Hampshire, United States
Job Summary
Lead and support internal audits, customer audits, and regulatory inspections from preparation through closeout while serving as audit host or back-room manager. Drive site inspection readiness by partnering with cross-functional teams and coaching subject matter experts. Plan, execute, and report on internal GMP audits including risk assessment, checklist development, and agenda creation. Author and review audit reports to identify compliance risks and GMP impacts. Ensure timely closure of audit observations, CAPAs, and quality system records while escalating compliance risks to leadership. Promote a culture of GMP compliance, apply data integrity principles, and mentor team members to develop future lead auditors. Collaborate with senior QA leadership on strategic quality initiatives.
Required Qualifications
- Bachelor's degree in Life Sciences, Biology, Chemistry, Pharmaceutical Sciences, or related field
- 8+ years of QA experience in a GMP-regulated environment (pharma, biopharma, or biologics manufacturing)
- Strong working knowledge of GMP regulations (FDA, EMA, ICH) and inspection readiness expectations
- Proven experience leading internal audits, customer audits, and regulatory inspections
- Hands-on experience with CAPA management, deviations, and quality systems
- Familiarity with electronic quality systems such as TrackWise or similar platforms
- Strong understanding of data integrity principles and regulatory expectations
- Excellent communication skills with the ability to influence and collaborate across all levels
- Ability to manage multiple priorities in a fast-paced, highly regulated environment
- High attention to detail with strong organizational and problem-solving skills
- Certified Quality Auditor (CQA) or similar certification
- Experience in biologics, aseptic processing, or cell & gene therapy environments
Desired Qualifications
- advanced degree
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