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 to determine roadmap to achieve project milestones.
* Design and execute experiments encompassing lab investigations, analytics method development, validation and transfer.
* Cross-functional teamwork – R&D, clinical operations, manufacturing and regulatory affairs teams.
* Ensure compliance with regulatory standards.
* Ensure QC activities meet company timelines 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.
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