Associate Director of QC Bioassay Lead, Cork

Job Description

Careerwise is partnering with a leading pharmaceutical client to hire an Associate Director Bioassy QC Lead for a pharmaceutical company based in Louth. This is your chance to step into a high-impact leadership role where you’ll drive quality excellence, lead a strong QC team, and play a key part in delivering vaccine products that make a real difference globally !!! THE ROLE 

Develop and lead a world-class Bioassay team QC team, including planning, recruiting, coaching, and training. This role will enable you to shape and enhance our team’s capabilities.Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment.Prepare, review, and approve technical documents such as method protocols and validation reports.Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities.Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs.Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency.Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs.Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures. 

REQUIREMENTS 

BSc or MSc in Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field.Strong understanding of analytical anMinimum of 5- 8 years of vaccine industry experience preferred, or minimum 5 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing.Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.Proven track record working cross-functionally across a wide variety of technical, business, and operational areas. Required Skills: Analytical Method Development, Cell Cultures, Deviations, GMP Compliance, Laboratory Management, People Management, Potency Assays, Quality Control (QC), Vaccine Manufacturing, Virology Preferred Skills: Biosafety, Vaccine Safety.