- Head of Quality Assurance (QA systems officers, Pharmaceutical Specialist and QP’s)- Act as a Qualified Person- Management team member- Contamination Control Strategy implementation- IGJ and FDA inspections

Head Quality Assurance and QP departmentCMC strategyQuality management Management team memberIGJ inspectionsDevelopment and manufacturing improvement plans

Global department head QA {US/NL)Responsible for GMP/GDP/GCPCMO managementOverall responsible for QA CMC strategy, small and large molecules. Discontinuation of position, Aduro Biotech moved all activities to the US

I am responsible for supervising the QC Chemistry, Bioassay and support disciplines, which is tasked to perform the the release and stability testing of Intermediates, Drug Substance and Drug Product for our Biologics programs.• Supervise the Researchers and Analysts within the QC Chemistry, Bioassay and support disciplines performing the QC testing of our biologics.• Ensure the analytical methods for the various clinical programs are properly validated and maintained in a controlled state.• Ensure relevant department performance indicators are measured and reported.• Participate in establishing department goals, and perform year-end reviews with personnel within the QC department.• Take part in CMC projects as Quality Control representative.• Be responsible for maintaining the GMP-compliant state of the QC laboratory.. Improvement of communication structure and teambuiling sessions - support in IMPD/IND writing

- Implementing and updating Pharmaceutical Quality System based on ICH, EMA and FDA for a new production site & QC laboratory.- Qualification of equipment, systems and buildings- Validation of computerized systems- Validation/Qualification/transfer of Analytical methods- Handling of risk assessments, deviations and changes- Provide training - Perform audits (internally, externally)- Severall quality based projects to improve the Pharmaceutical Quality System of Synthon

- Werken bij verschillende opdrachtgevers op locatie als kwaliteits/project manager- implementeren, onderhouden, verbeteren en structureren van projectmatig bedrijfsprocessen; - procesbeheerssystemen zoals BRC, HACCP, IFS en ISO 22000; - bepalen van kwaliteits- en voedselveiligheidsdoelstellingen - Uitvoeren en analyseren van kwaliteitsmetingen; - Uitvoeren en interpreteren van productie-inspecties en systeemanalyses; - Uitvoeren van audits.

Batch record reviewTraining, GMP training Quality System Internal and External auditsContact person to R&D, for QA related issuesChange controlDeviation and CAPAetc

- Assist in setting up a laboratory in the Netherlands and Denmark- Create a quality environment - Review of batch documentation and Quality Control test results- Trainingscoordinator

working at the VPT (vail product testing)performed different kind of testeg: Elisa, cell based assays, HPLC (SEC, rHPLC etc), SDS-page, visible particles, IEF etcresponsible for release timelines of stability testing.