Associate Director, Global GMP Compliance
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.
In this role you will plan and execute a program of corporate GMP (Good Manufacturing Practice) 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 APIs, medical devices and excipients but also covering food, feed and dietary supplements. Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements.
You will advise, guide and support sites in the overall regulatory inspection management. Provide expertise to sites and the global organization on GMP compliance and best practices as well as new and developing GMP regulatory requirements and trends - 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)
- Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads
Regulatory Inspection Management
- Conduct pre-approval/pre-submission project reviews (e.g. products, facilities), “mock” inspections as part of the Global GMP Compliance Assessment program.
- Provide guidance for timely remediation, advise, guide and support sites in the overall regulatory inspection management
- In cooperation with other Global Quality functions, review and provide input to responses following regulatory inspections
GMP Compliance Risk Management
- Perform regular analysis of regulatory observations made at Lonza’s sites, prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence and provide advice to the sites
- Provide expertise to sites and the organization on new and developing GMP regulatory requirements and trends, to help ensure the company remains up-to-date with current GMP
- Lead or participate in the continuous improvement and maintenance of a global platform for reporting, reviewing and trending GMP Compliance risks on a global basis
Quality/Compliance projects and standards
- Participate in or lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives
- Fulfil role as a compliance reviewer and approver of CORP and GROUP GMP procedures and policies
- Develop and maintain CORP and GROUP Quality standards and processes based on expertise and assigned areas and ensure expertise in GMP is kept current through involvement in Industry forums and conferences
- 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. USFDA
- 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 and CSV (advantageous)
- 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.