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
Requirements
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
Ready to shape the future of life sciences?
Benefits
Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
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.
Lonza · Us - Portsmouth, NH