Mackenzie Stuart have been retained by an innovative global animal health company, who are searching for a Quality Control Manager to lead the execution of various activities related to the development, implementation and validation of several assays. The QC Manager will partner with the RA & Product Development functions, playing a key role in supporting the global registration and commercialization of the innovative biological pipeline.

Key Responsibilities:

Working with PDRA determine roadmap to achieve project milestones.Design, and execute experiment encompassing lab investigations, analytics method development, validation and transfer.Cross functional teamwork – R&D, clinical operations, manufacturing and regulatory affairs teams.Ensures complications with regulatory standards.Ensure QC activities meeting company timeline and goals.Ensure validated QC methods are implemented across manufacturing sites.

Qualifications

Must be EU based (50% home office, 50% based at corporate office)MS or PhD in (veterinary, biology, biotechnology, chemistry, medicine or related field).+5 years’ experience with MS, or +2 years’ experience with PhD.Experience in analytical, microbiological, and small and large animal quality control testing, assay validation, and stability studies.Understanding of cGxP in pharmaceutical manufacturing.Knowledge of EMA Regulations and ICH Guidelines.