QA Specialist V - QA Inspection Audit Management
Lonza•Portsmouth, NH
•Onsite
About The Position
The QA Specialist V – Inspection & Audit Management plays a critical role in ensuring site-wide compliance with GMP and regulatory requirements. This individual will lead and support internal audits, customer audits, and regulatory inspections, partnering closely with cross-functional teams and senior leadership to drive inspection readiness and continuous improvement. This role is highly visible and requires strong audit expertise, communication skills, and the ability to influence a culture of quality and compliance across the organization.
Requirements
- 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
Nice To Haves
- Advanced degree preferred
- Certified Quality Auditor (CQA) or similar certification preferred
- Experience in biologics, aseptic processing, or cell & gene therapy environments is a plus
Responsibilities
- Lead and support internal audits, customer audits, and regulatory inspections from preparation through closeout
- Serve as audit host and/or back-room manager, ensuring effective coordination and communication during audits and inspections
- Drive site inspection readiness by partnering with cross-functional teams and coaching SMEs
- Plan, execute, and report on internal GMP audits, including risk assessment, checklist development, and audit agenda creation
- Author and review audit reports, ensuring clear identification of compliance risks and GMP impact
- Contribute to the Annual Internal Audit Plan and Annual Internal Audit Report
- Ensure timely closure of audit observations, CAPAs, and quality system records
- Partner with stakeholders to develop effective corrective and preventive actions
- Escalate compliance risks and trends to leadership as appropriate
- Promote a strong culture of GMP compliance and quality awareness across the site
- Identify areas for improvement and support implementation of best practices
- Apply Data Integrity principles in all aspects of work
- Mentor and train team members in audit practices and inspection readiness
- Support development of future lead auditors
- Collaborate with senior QA leadership on strategic quality initiatives
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid time off (PTO)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
