QA Specialist V - QA Inspection Audit Management

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza in Portsmouth, NH seeks a QA Specialist V to lead and manage QA inspections and audits. The role focuses on site-wide GMP compliance, leading internal, customer, and regulatory audits, and driving inspection readiness with cross-functional teams.

Responsibilities include planning and executing GMP audits, CAPA management, and promoting a culture of quality. Strong communication and audit expertise are essential, with preference for CQA certification and biologics/aseptic experience.

Qualifications

• 8+ years of QA experience in a GMP-regulated environment.
• Experience leading internal audits, customer audits, and regulatory inspections.
• Familiarity with electronic quality systems such as TrackWise or similar platforms.
• Strong knowledge of GMP regulations (FDA, EMA, ICH) and inspection readiness.
• Excellent communication and collaboration across all levels.
• Experience with CAPA, deviations, and quality systems.

Responsibilities

• Lead and support internal audits, customer audits, and regulatory inspections.
• Coordinate audit activities as host and back-room manager.
• Drive site inspection readiness by partnering with cross-functional teams.
• Plan, execute, and report internal GMP audits, including risk assessment and audit agendas.
• Author and review audit reports, identifying compliance risks and GMP impact.
• Ensure timely closure of audit observations, CAPAs, and quality system records.
• Promote GMP compliance and a strong quality culture across the site.
• Mentor and train team members in audit practices and inspection readiness.
• Collaborate with senior QA leadership on strategic quality initiatives.

Skills

GMP knowledge

Audit leadership

CAPA management

Data integrity

Regulatory inspections

Communication skills

Education

Bachelor's degree Life Sciences

Tools

TrackWise

Job description

QA Specialist V - QA Inspection Audit Management

United States, Portsmouth (New Hampshire)

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

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.