QC Manager

For our new biomanufacturing facility in Leiden we are looking for a QC Manager

The Manager QC is responsible for the execution of the QC releases for incoming goods, intermediates and final products. Also cleanroom qualification, e.g. EM monitoring and utility monitoring are in scope, as well as trend reporting.

The Manager QC maintains an overview and ensures that aspects of: People, Safety, Quality, Delivery and Cost are managed throughout his/her departments.

He/she interacts and aligns with Operations, QA, Engineering and Maintenance, Planning, Procurement and other functions in the Batavia Biomanufacturing organization.

• Ultimately responsible for setting up and maintaining the QC laboratory (Bioanalytical and microbiology).

• Responsible for the selection, training, coaching, qualification and management of QC personnel.

• Accountable for laboratory equipment and the routine maintenance of the laboratory.

• Ultimately responsible for appropriate resource planning, planning of execution of test methods and reporting of valid results.

• Contribute to the development of the Quality strategy and business goals in light of budget, resources, processes and investments.

• Accountable for adequate transfer-in and establishment of analytical-, microbiological methods, such as qPCR, HPLC, cell based assays, sterility tests, endotoxin testing.

• Proficient in generation, review and approval of SOPs, work instructions, Deviations, and other GMP documentation

• Perform review of high level GMP documentation,

• Accountable for the overall GMP level of the QC department and compliance with all EU and FDA GMP regulations and guidelines. Participate in client audits and government agency inspections

• Management experience within a QC Bioanalytical lab environment and/or Microbiology lab in a commercial manufacturing facility.

• Experience with defining job profiles, training requirements and training of analysts

• Solid understanding of pharmacopoeias, GMP, GLP and associated regulations.

• Proficient in English language (Dutch knowledge is a plus).

• Adaptive and flexible.

• 10+ years experience in a GMP environment in a biopharmaceutical setting

• Experience in writing/reviewing Deviations, CAPA and Changes

• Quality Systems knowledge

• Good decision-making skills

Preferred Skillsets/Experience

• Participated in method transfer/verification and validation of QC test methods

• Familiar with trend analysis and method performance monitoring