Quality Operations Lead

Quality Operations Lead

This position is critical to ensure sustainable compliance of biological and vaccine products, processes, and systems with our Company’s requirements and regulatory requirements.

He/she will perform quality oversight on biological and vaccine testing and packaging operations.

• Batch record review and Release biological and vaccine products
• Preparation and review of documentation related to biologics and vaccine operations related to external testing facilities
•  Perform and review investigations related to analytical testing and packaging quality issues
•  Perform and review corrective and preventive actions (CAPA), change control, etc
• Perform improvement activities at biological and vaccine operations in quality
• Be a counterpart for site quality with local/global manufacturing sites

Skills (include specific skill levels required to apply our Company's Leadership Principles)

• Degree in Life Sciences, Pharmacology, or Science.
• Minimum of 3 years experience in the regulated pharmaceutical environment; preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
• Knowledge of biochemistry, testing knowledge on biological products
• Knowledgeable of Industry Best Practices for quality and compliance-related topics.
• Strong collaboration and cross-functional leadership skills to drive continuous improvements
• Preferably have project management skills.
• Preferable to have English language skills.