Global Associate Director, Quality Compliance

public.client.lonza.display.name; Portsmouth (VA); Remote; USD 120,000 - 180,000; Full time

Job summary

Lonza seeks a Global Associate Director of Quality Compliance to oversee compliance and audit programs across its manufacturing sites. This remote position supports the quality of sterile and non-sterile drug products, ensuring adherence to regulatory standards. Candidates should possess a Master's in Life Sciences and extensive experience with cGMPs, particularly in the life sciences sector.

Qualifications

• Deep knowledge of cGMPs and regulatory processes.
• Extensive GMP auditing experience, especially in cell/gene therapy.
• Experience in supplier qualification and risk management.

Responsibilities

• Develop audit plans and execute GMP compliance audits.
• Support regulatory inspections and provide guidance.
• Analyze regulatory observations and ensure CAPA effectiveness.

Skills

Knowledge of cGMPs

Auditing

Risk Management

Education

Master's in Life Sciences

Job description

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Job Summary:

The Global Associate Director, Quality Compliance supports the overall Lonza strategy to gain and maintain the license to operate. This is achieved by lowering the quality and compliance risk through audits, advising the sites to reach an optimum state of compliance. Develop, plan and execute a program of corporate GMP compliance audits/assessments for Lonza’s manufacturing sites and operations with a focus on sterile and non-sterile drug products (including solid dosage forms, biologics, cell/gene therapy), biological and chemical APIs, medical devices and excipients. This also covers food, feed and dietary supplements and sites involved in software and hardware manufacture. Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements. Support sites in preparing for and managing regulatory inspections. Provide expertise on GMP compliance, best practices, and emerging regulatory trends. Perform supplier quality assessments and audits, follow up on CAPAs, and act as Single Point of Contact for suppliers from a global portfolio.

This position can be remote 100% for the right candidate, with periodic visits to Portsmouth, NH.

Key Responsibilities:

Internal Audit/Assessment Management

• Develop audit plans based on risk, regulatory focus, and business needs.
• Execute GMP compliance audits as lead or co-auditor, produce detailed reports, and follow up on findings.
• Support remediation actions, review CAPA plans, and maintain audit documentation.

Regulatory Inspection Management

• Support pre-approval projects, mock inspections, and provide guidance during actual inspections.

Supplier Audit/Assessment Management

• Develop audit plans, execute supplier audits, produce reports, and ensure CAPA effectiveness.

Quality Compliance Risk Management

• Analyze regulatory observations, provide trend analysis, and support continuous improvement.

Projects and Standards

• Lead or participate in quality projects, review and approve GMP procedures, and develop standards.

Other Activities

• Stay current with GMP industry forums, provide site support, and mentor team members.

Stakeholder Management & Leadership

• Support onboarding, training, and provide feedback to promote a quality culture within the team.

Key Requirements:

• Master's in Life Sciences preferred; experience considered.
• Deep knowledge of cGMPs, regulatory processes, and proven experience with FDA, EMEA, and other authorities.
• Extensive GMP auditing experience, especially in cell/gene therapy, biologics, or related fields.
• Experience in supplier qualification and risk management.
• Training or knowledge of EU Qualified Person responsibilities is a plus.

At Lonza, we are committed to ethical practices, environmental protection, and diversity. We offer the chance to work on impactful projects in life sciences, making a difference in people's lives.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, religion, or other protected characteristics.