Quality Operations Supervisor

Quality Operations Supervisor

The Quality Operations Supervisor is a hands-on leadership role responsible for overseeing daily Quality Operations activities and ensuring compliance with cGMP and regulatory requirements across multiple sites. This position involves operational quality oversight, direct engagement in batch record review, deviation management, and on-the-floor support, while managing staff. The role serves as the primary interface between site operations and Quality Operations leadership, providing proactive support to Manufacturing, Warehousing, and QC operations, and ensuring product quality and compliance objectives are consistently met.

Responsibilities

• Ensure site-wide GMP compliance and product quality.
• Apply advanced knowledge of GMP, quality, and risk management to identify and mitigate potential risks or process gaps.
• Serve as the Quality primary point of contact between site operations and QO leadership.
• Provide hands-on, on-the-floor QO support in manufacturing cleanrooms, warehouse operations, and QC laboratories.
• Review and approve deviations, CAPAs, and Change Controls.
• Oversee critical quality activities including apheresis material receipt, production document issuance, batch record review, and final product shipment.
• Review and approve GMP documentation to ensure compliance and accuracy.
• Supervise, mentor, and develop QO staff.
• Promote a strong culture of quality, compliance, teamwork, and accountability within the QO team.
• Coordinate with cross-functional teams to allocate resources and resolve operational challenges.
• Contribute to continuous improvement of QO processes.
• Support audit and inspection readiness, and serve as SME during client and regulatory interactions.
• Lead continuous improvement initiatives to enhance compliance, efficiency, and operational excellence.

Essential Skills

• 5+ years of experience in Cell/Gene Therapy OR MS/PhD in a relevant field.
• 3+ years of people management experience.
• Experience with QMS - CAPA investigations and deviations oversight.
• Strong knowledge of GMP, quality systems, and risk management principles.
• Hands-on experience providing QO support in GMP environments.
• Excellent organizational, communication, and problem-solving skills.
• Flexibility to work shift-based schedules and travel between sites as needed.

Additional Skills & Qualifications

• Bachelor's degree in a scientific discipline (Biology, Chemistry, Microbiology, or related) with 57 years of experience in GMP/Quality Operations.
• Master's degree with 35 years relevant experience preferred.
• In-depth knowledge of GMPs and ability to apply them in compliance with U.S., EU, and global regulatory standards.
• Experience with cell and gene therapy manufacturing in clinical or commercial settings.
• Expertise in aseptic manufacturing processes.

Pay and Benefits

The pay range for this position is $100000.00 - $110000.00/yr. 401k medical dental vision

Workplace Type

This is a fully onsite position in Edison, NJ.

Application Deadline

This position is anticipated to close on Oct 31, 2025.