QA Specialist V - QA Inspection Audit Management

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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

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