QA Specialist V – QA Inspection Audit Management

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What you will get:

Below you will find a comprehensive summary of the benefits package we offer:

• 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).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What will you do:

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.

Audit & Inspection Management

• 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

Internal Audit Program

• 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

Compliance & CAPA Management

• 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

Continuous Improvement & Quality Culture

• 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

Training & Leadership

• 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

What we are looking for:

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Pharmaceutical Sciences, or related field (advanced degree preferred)

• 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 preferred

• Experience in biologics, aseptic processing, or cell & gene therapy environments is a plus

Ready to shape the future of life sciences? Apply now.