Job Description
Careerwise is partnering with a leading pharmaceutical client to hire an Associate Director Bioassay 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.
Responsibilities
Develop and lead a world‑class Bioassay QC team, including planning, recruiting, coaching, and training to shape and enhance the 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.
Qualifications
BSc or MSc in Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field.
Strong understanding of analytical methods.
Minimum 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 include Analytical Method Development, Cell Cultures, Deviations, GMP Compliance, Laboratory Management, People Management, Potency Assays, Quality Control (QC), Vaccine Manufacturing, Virology. Preferred skills include Biosafety, Vaccine Safety.
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