Senior Specialist, Global Quality and Compliance – Animal Health

Responsibilities

• Serve as a Global Reg Intelligence coordinator (lead) for QMS Regulations Management Process and support the Compendial Review Process.
• Lead the QMS Regulation Management process and main liaison with Clarivate (service provider) including administrative activities to ensure Global Animal Health Manufacturing (GAHM) compliance state.
• Responsible for evaluating regulation updates for several countries and issuing administrative tasks to ensure sites compliance state.
• Serve as Back‑up for Animal Health Quality Manual (AHQM) Coordinator.
• Provide training and coaching to site personnel as needed to support the processes.
• Other duties as assigned.

Requirements

• 8+ years’ experience in Animal Health biological vaccine and/or pharma manufacturing, quality control, regulatory affairs and/or quality assurance.
• Knowledgeable of GMP regulations and requirements.
• Knowledgeable of or willing to learn international regulatory requirements.
• Detail oriented, self‑motivated, displays critical thinking and able to work independently.
• Has experience leading-through-influence, remotely and in-person, to meet desired outcomes.
• Displays continuous improvement mindset.