Quality Assurance Operations Manager - Meet

W2 Only

*Remote (Will work EST hours)

12 Month Contract

Overview:

Our client is seeking a Manager of Quality Assurance Operations to join their team. This role will support all GMP aspects of drug product (DP) manufacturing, CMC, and alliance management. The Manager will collaborate closely with internal teams and external partners to ensure clinical through commercial lifecycle activities comply with cGMP regulatory requirements and guidelines. This position reports to the Director of Quality Assurance.

This is a remote position, with working hours aligned to the Eastern Time (EST) zone.

Key Responsibilities:

• Provide quality oversight of external manufacturing for both clinical and commercial drug products, including lot disposition.
• Review and approve internal and external Deviations, Change Controls, and CAPAs.
• Support the review and data verification of clinical regulatory filings.
• Collaborate with alliance partners to ensure compliance with their quality systems and practices related to drug product manufacturing and disposition.
• Assist in establishing best practices with alliance partners to ensure consistent quality standards.
• Partner with internal teams and external vendors to address complex quality issues, ensuring compliant solutions that meet patient needs.
• Ensure timely and accurate reporting of key performance indicators (KPIs) and risk metrics.
• Drive continuous improvement initiatives to proactively mitigate risks and maintain effective operations to support business needs.

Qualifications:

• Bachelor’s degree in life sciences, engineering, or a related field.
• Minimum of 5 years of experience in a pharmaceutical or biopharmaceutical Quality Assurance role with increasing responsibility.
• Experience working with external Contract Manufacturing Organizations (CMOs) in a virtual environment.
• Strong knowledge of aseptic techniques and parenteral drug manufacturing operations.
• Hands-on GMP management experience, including exposure to regulatory authorities such as FDA, EMA, PMDA, or equivalent.
• Experience in Quality Operations roles for both investigational and commercial products is preferred.
• Proven experience collaborating with alliance partners to ensure compliance and drive best practices.
• Demonstrated ability to identify inefficiencies, improve processes, and enhance turnaround times.