Key skills
Critical Thinking
About this role
Role Overview
- 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
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days