Quality Control Manager – Animal Health

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.