Quality Control Supervisor

Quality Control Supervisor

This hands-on leadership role is responsible for executing and overseeing daily Quality Control operations in the Analytical and Microbiological laboratories within a cGMP environment. The Quality Control Supervisor will be fully qualified on assays, actively perform and troubleshoot testing, and provide technical guidance while managing staff scheduling, training, and workload distribution. This role ensures that QC testing in support of cell therapy products is executed on time, to the highest quality standards, and in compliance with cGMP. The position supports both the Princeton and Newark sites, providing direct quality control oversight and operational support across these locations.

Responsibilities :

• Perform analytical and microbiological testing (e.g., Flow Cytometry, PCR, ELISA, Sterility, Endotoxin, Bioburden) as part of routine QC operations across sites.
• Support the ramp-up of new assays and technologies to meet evolving client and regulatory needs.
• Maintain assay qualifications and act as a technical resource for troubleshooting methods, equipment, and operational issues across sites.
• Supervise QC Specialists, including scheduling, training, mentoring, and performance management.
• Balance hands-on testing responsibilities with oversight of team activities to ensure timely support for in-process, release, and stability testing.
• Coordinate with Manufacturing, Quality Operations, QC Management, and cross-functional teams to allocate resources and resolve operational challenges.
• Support multiple client programs by ensuring project-specific quality documentation, records, and deliverables are reviewed and maintained in compliance with standards and regulatory requirements.
• Assist with client audits and inspections, prepare documentation, coordinate logistics, and ensure timely responses to client requests.
• Participate in technical transfers and cross-site initiatives by supporting documentation review, process alignment, and communication between teams.
• Ensure laboratory compliance with SOPs, company policies, and applicable regulatory standards (FDA, EMA, USP, ICH).
• Ensure integrity and compliance of electronic data systems (e.g., LIMS) with regulatory expectations.
• Support method transfers, qualifications, and validations for assays, equipment, and utilities.
• Review and approve QC records, ensuring accuracy, compliance, and data integrity.
• Lead or support investigations, deviations, CAPAs, and Change Controls.
• Monitor and report trends in environmental monitoring, analytical results, and lab performance metrics.
• Contribute to continuous improvement of QC processes, including authoring and approving SOPs and training materials.
• Support audit and inspection readiness and serve as SME during client and regulatory interactions.

Essential Skills :

Additional Skills & Qualifications :

Work Environment :

This position is based in a growing CDMO focused on Cell / Gene Therapy, with operations at a brand-new site. The work environment includes state-of-the-art laboratory equipment and facilities designed to support the development and manufacturing of advanced therapy products.

Job Type & Location :

This is a Permanent position based out of NA, New Jersey.

Pay and Benefits :

The pay range for this position is $100000.00 - $110000.00 / yr.

Workplace Type :

This is a fully onsite position in Princeton, NJ.

Application Deadline :

This position is anticipated to close on Oct 27, 2025.

About Actalent :

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for other accommodation options.