As CQO, I represent Quality on the four-person Management Team of Produlab Pharma and am ultimately responsible for R&D, Sterility Assurance, Quality Assurance, Quality Control, Quality Improvement and Validation (~80 FTE), with direct reports from the Heads of Laboratory and QA, 2 QPs/RPs, and 6 Quality Specialists.

As Head of QC I was responsible for the Quality Control department (35 FTE), with direct reports from the Chemistry, Microbiology and Laboratory Administration Teamleaders. My main tasks were professionalizing the organizational structure, increasing compliance and quality level, and improving efficiency and interdepartmental alignment.

Topics: Drug formulation stability and (ongoing) stability study design

Workgroup for providing feedback on the draft European Pharmacopoeia monographs that are published in Pharmeuropa on behalf of the Dutch Pharmacopoeia Authority.

Apotheek A15 (Pharmacy A15) is a newly built, GMP certified facility for the development and (sterile) manufacturing of hospital specific medication that is not commercially available in the EU. It is a joint venture between the hospital pharmacies of Erasmus University Medical Center, University Medical Center Groningen, University Medical Center Utrecht and Radboud University Medical Center, that was established in 2013.During the startup I was responsible and/or consulting for the design and construction of the chemistry and microbiology labs, the purchase and qualification of analytical equipment, development of the laboratory quality handbook, analytical method transfers and manufacturing process and cleaning validations.As Laboratory Lead I had 15 direct reports from QC and R&D Analysts and was SME for laboratory GMP compliance and continuous improvement.

As Research Analyst I was responsible for the development and validation of stability indicating analytical methods for new hospital specific drug formulations and clinical trial medication.

As Analyst QC & TDM I performed quality control (QC) testing on raw materials and finished products for necessary medicines that are manufactured in small batches in the hospital pharmacy, for which there is no available registered equivalent. Additionally, I performed diagnostic tests for therapeutic drug monitoring (TDM) on human samples.