Global Associate Director Quality Compliance at Lonza, Apply Now!
Looking for a high-impact role in global life sciences? Lonza is hiring a Global Associate Director of Quality Compliance to lead GMP audit and regulatory initiatives across continents. From supporting regulatory inspections to managing supplier audits and internal assessments, this fully remote opportunity lets you shape compliance strategy for life-saving innovations. Explore how your expertise can make a worldwide difference with Lonza.
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, thereโs 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 thatโs 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 Lonzaโs manufacturing sites and operations with a focus on:
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Sterile and non-sterile drug products (solid dosage, biologics, cell/gene therapy)
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Biological and chemical APIs
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Medical devices, excipients, food, feed, and dietary supplements
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Software and hardware manufacturing
The role also advises and supports remediation efforts to meet regulatory expectations, guides sites in inspection readiness, and performs supplier quality assessments/audits to ensure uninterrupted supply.
This position can be 100% remote for the right candidate, with occasional travel to Portsmouth, NH.
Key Responsibilities
Internal Audit/Assessment Management
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Develop audit plans based on risk and regulatory focus
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Conduct Global GMP audits for internal sites at all risk levels as Quality Compliance
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Report findings with appropriate references
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Support and monitor CAPA remediation plans
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Provide guidance on third-party audits
Regulatory Inspection Management
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Lead mock inspections and pre-submission project reviews
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Offer on-site regulatory inspection support as Quality Compliance
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Input on post-inspection commitments
Supplier Audit/Assessment Management
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Lead supplier audits using risk-based agendas
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Report findings and track CAPA outcomes
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Contribute to supplier performance reporting
Risk Management
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Analyze regulatory trends to mitigate repeat observations
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Contribute to global risk reporting platforms as Quality Compliance
Quality Compliance Projects & Standards
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Participate in corporate quality improvement projects
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Develop and review quality procedures and standards
Other Activities
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Stay current with GMP via industry engagement
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Support Lonza sites as needed
Collaboration & Leadership
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Mentor and train audit team members
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Promote inclusive leadership and quality culture as Quality Compliance
Key Requirements
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Masterโs in Life Sciences (preferred) or equivalent experience
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Deep knowledge of cGMPs and global regulatory processes
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Proven track record with FDA, EMEA, and Health Authorities
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Extensive auditing experience across multiple product types
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Experience in supplier qualification, risk management, and EU QP responsibilities
Keywords: Global Associate Director Quality Compliance, GMP audits, regulatory inspection management, supplier audit, life sciences job
