QA Specialist V - QA Inspection Audit Management

QA Specialist V – Inspections and Audit Management

Location: Portsmouth, NH (On-site)

Join our Quality Systems team and play a key role in ensuring compliance and excellence across internal audits, customer audits, and regulatory inspections. Your expertise will help us maintain the highest standards in GMP and quality culture.

What you will get:

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• Medical, dental, and vision insurance.

• Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
   

What you will do:

• Lead or support internal audits, including planning, execution, and reporting.

• Prepare and manage activities for customer audits and regulatory inspections.

• Act as host or back-room manager during audits and inspections.

• Coach subject matter experts on audit interactions and compliance expectations.

• Ensure timely closure of quality system records and escalate compliance risks when needed.

• Mentor and train other QA Specialists in audit and inspection processes.

• Apply data integrity principles and maintain GMP compliance in all activities.
   

What we are looking for:

• Bachelor’s degree in a scientific or technical field (or equivalent experience).

• 10+ years of experience in GMP environments and quality assurance.

• Strong knowledge of FDA, EMA, and ICH regulations.

• Direct experience with regulatory inspections and customer audits.

• Excellent communication and presentation skills.

• Ability to lead in high-pressure situations and manage multiple priorities.

• Certified Quality Auditor (CQA) preferred.
   

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.