Associate Director, Global Good Manufacturing Practices (GMP Compliance)
Portsmouth, New Hampshire
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
To strengthen our Lonza Global Good Manufacturing Practice (GMP) Compliance Department, we are looking for an exceptional Associate Director, Global GMP Compliance reporting to the Head Global GMP Compliance. The purpose of the role is to plan and execute a program of corporate GMP compliance audits/assessments for Lonza’s GMP sites and operations with a focus on sterile and non-sterile drug products (including cell and gene therapy, biologics, oral dosage forms), biological and chemical Active Pharmaceutical Ingredients, medical devices but also covering food, feed and dietary supplements. The role will involve a large amount of international travel (up to 50%).
- Global GMP Compliance Audit/Assessment Management
- Develop audit plans/agendas for corporate GMP compliance assessments/audits based on risk
- Execute corporate GMP compliance audits/assessments (as lead or co-assessor/auditor)
- Produce timely, detailed and technically correct reports following assessments/audits
- Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads
- Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements.
- Assess the adequacy and approve proposed Corrective And Preventative Action (CAPA)/ remediation plans, regularly review progress & effectiveness, and continue to give ongoing support in all compliance matters
- Complete and maintain the corporate internal audit/assessment documentation and follow-up/tracking system
- Regulatory Inspection Management
- GMP Compliance Risk Management
- Quality/Compliance projects and standard
- MSc in biochemistry/biologics, chemistry, pharmacy or equivalent
- Excellent knowledge of and working experience with international GMP regulations and guidelines especially US / EU for Drug Products including aseptic manufacturing, APIs (biotechnology derived: cell culture/fermentation and chemical) medical devices, and excipients . Experience in Cell and Gene Therapy is beneficial
- Extensive experience as a GMP auditor and in regulatory inspection management incl. US Food Drug Administration (FDA)
- Thorough operational experience in Quality Assurance / Quality Management for Drug Products and biological, chemical APIs
- Proven experience in compliance related remediation, working knowledge of the GMP quality management concepts, risk management techniques
- Excellent oral and written English communication skills plus preferably other languages
- Experience in Data Integrity
- Experience in pharma/biotech operations (advantageous
- Prior experience as a regulator is beneficial
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.