Manager – Quality Assurance Operations

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 firsthand 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.