Wassenaar, South Holland, Netherlands
I am available from December 2026. I have over 20 years’ experience within the Quality Unit and over 3 years’ experience as a QP, with a strong technical, regulatory and analytical background through experiences in Quality Assurance, In-Process Control and Quality Control. Areas of expertise include GMP, GDP, Quality Management Systems and Validation/Qualification processes.
• Provided Quality oversight for equipment and facilities at internal and external sites, covering 17 sites across Europe and the US. • Remediated Facility Design resulting in a reductions of Environmental Excursion from 4 excursions a week to one in 6 months at the Leiden Facility • Implemented a new Strategy and Structure over the Equipment Lifecycle process introducing a risk based approach and ISPE best practices • Designed 2 new facilities in Pittsburgh covering warehouses, cleanrooms and laboratories. • Defined Strategy, Execution and provided oversight for the decommissioning of equipment at 17 facilities due to Company Wind down • Guided improvements to the Aseptic Process Simulations at all manufacturing sites • Trained personnel in new process as part of Quality Management System Enhancements. • Managed small team of consultants • Winner of the Global Quality Award for Collaboration due to my ability to work with multiple teams with different point of views and find consensus
• Transitioned site from R&D to full GMP • Redesigned full manufacturing facility for the installation of two new injectable fill lines to be in full compliance with Annex 1 • Initiated the QA department, expanding from 1 to 5 members
• Performing QP release of cell banks, drug substances and drug products for phase 1 – 3 clinical trial material. • Member of Janssen’s Covid Vaccine Task Force, involved in the tech transfers and PPQs at multiple facilities in Germany, India, Italy, South Africa and the US. • Go-To trouble-shooter for problematic projects to ensure adherence to quality and business objectives • Assisted CMO in India for approval by the FDA, the first ever Indian vaccines company to get approval by the FDA. • Lead Auditor for Janssen vaccines and have completed multiple audits as Lead, covering analytical laboratories, cell bank manufacturing, drug substance and drug product manufacturing, in multiple countries • Involved in multiple projects from early to late phase development as a Quality liaison for Drug Product, Drug Substance and Cell Banks • Managed QA Operations Team with direct reports, and part of the Quality Leadership Team • Chair of the Specification Review Committee
• Involved in multiple projects from early to late phase development as a Quality liaison for Drug Product • Managed multiple Contract Manufacturing Organisations for the manufacturing of Clinical Trail Material and ongoing stability programs and resolved any conflicts that arose. • Conducted Audits at CMOs/CLOs and Supported Mock Pre-Approval Inspections at CMOs • Reviewed and Approved CMO Change Controls, Deviations and Batch Records. • Resolved Complaints from CMOs in a timely manner • Handled multiple Tech Transfers to and from CMOs • Successfully implemented multiple PPQs for the numerous vaccines, including Drug Substance and the Prime and Boost Drug Product at CMOs • Guided late-stage development studies to ensure later compliance • Advised during criticality analysis implementations • Managed all Shipping Route Verification activities for Leiden Vaccines
Executed QP activities over QC release in combination with the QP release at our CMO Increased GMP compliance and knowledge through upgrading of outdated procedures and thorough training. Implemented an Electronic Quality Management System while Introducing Quality Management structures and techniques including KPIs and metrics. Performed external audits of CMOs as Lead Auditor and engaged in conflict resolutions with them. Approved and reviewed change controls, deviations, CAPAs and protocols to verify correct execution and compliance.
Redesigned and implemented a new quality management system appropriate for a research and development facility. Performed external audits of contract manufacturers and contract laboratories as Lead Auditor. Advised and assessed validation activities with a strong focus on data integrity, to ensure that the quality of all data generated could be guaranteed if required for regulatory approval of new drug products. Approved and reviewed change controls, deviations and research protocols to verify correct execution and compliance