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Job Title: Quality Control SupervisorJob Description

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

+ 5+ years of experience in Cell/Gene Therapy or a Master's/PhD in a related field.

+ 3+ years of people management experience.

+ Proficiency in PCR, Flow Cytometry, and biology.

+ Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related) with 5–7 years of QC or GMP lab experience, including prior supervisory or leadership experience; Master’s degree with 3–5 years relevant experience preferred.

+ Proven technical proficiency in QC modalities relevant to cell therapy, including analytical assays (e.g., flow cytometry, PCR, ELISA, potency, identity, viability, immunophenotyping) and microbiological assays (e.g., sterility, endotoxin, bioburden, environmental monitoring).

+ Demonstrated ability to troubleshoot assays, instrumentation, and laboratory systems.

+ Experience with laboratory data systems, including LIMS and instrument/equipment qualification and compliance software.

+ Prior supervisory experience in a GMP laboratory setting.

+ Proven ability to lead change, drive culture, and influence across functions in a fast-paced, regulated environment.

+ Ability to manage schedules and resources while remaining directly engaged in laboratory testing.

+ Excellent organizational, communication, and problem-solving skills.

+ Flexibility to work shift-based schedules (including evenings, weekends, and holidays as needed).

Additional Skills & Qualifications

+ Experience with cell and gene therapy QC testing in clinical or commercial settings.

+ Demonstrated success leading investigations and supporting CAPA/Change Control processes.

+ Experience working in a multi-project, multi-client CDMO environment, including managing method transfers between clients/sites, supporting client audits and regulatory inspections, and ramping up new assays.

+ Familiarity with global regulatory requirements and expectations for advanced therapy products.

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.

401 medical dental vision

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, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.