Senior Quality Specialist

Job Summary

A company is looking for a Sr. Specialist, External Quality Small Molecules.

Key Responsibilities:

• Provide quality support to ensure effective execution of quality systems at external manufacturing sites
• Support quality oversight in the qualification and ongoing monitoring of external partners
• Review and approve quality systems documentation, including batch documentation and annual product reviews

Qualifications:

• A minimum of a Bachelor's or equivalent University degree is required, preferably in life science, engineering, or physical science
• A minimum of 8 years working in a cGMP regulated environment for Manager Level or 5 years for Sr Specialist Level
• Experience supporting quality oversight for pharmaceutical production, including cGMP compliance and non-conformance investigation
• Ability to work independently in support of a portfolio of products and external manufacturers
• Experience working on cross-functional project teams