Quality Assurance Operations Manager

The Manager of Quality Assurance Operations will work within the DP / CMC / Alliance QA Operations team and is responsible for providing support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance management.   This role will work cooperatively with their counterparts in Quality Operations to provide quality oversight to ensure clinical through commercial lifecycle activities meet cGMP regulatory requirements and guidelines.  This position reports to the Director of Quality Assurance.

Key Responsibilities

• Execute quality oversight of external manufacturing of both clinical and commercial drug product through lot disposition
• Provide QA review and approval of internal and external Deviations, Change Controls, CAPAs.
• Provide QA support for review and data verification of clinical regulatory filings
• Engage with alliance partners to assure compliance to their quality systems and...