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 practices as related to manufacturing through disposition of drug product. Support establishment of best practices with alliance partners
• Collaborate and support internal colleagues and external vendors to navigate complex quality issues, ensuring compliant solutions are explored and meet patient needs.
• Ensure timely and accurate metrics reporting for KPI and risk register tools
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.

Qualifications

• Minimum BS degree in life sciences, engineering or related field.
• A minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company in roles of increasing responsibility in Quality Assurance.
• Experience working with external Contract Manufacturing Organizations in a virtual setting.
• Experience with aseptic techniques and supporting parenteral drug manufacturing operations.
• Experience of first hand GMP management is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing.
• Experience working with investigational and commercial products in a Quality Operations role is preferred.
• Experience working with Alliance Partners is preferred.
• Experience driving out inefficiencies and improving turnaround times.