Site Lead, Quality Operations & GMP Compliance

About Made ScientificMade Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.Position SummaryThe Site Lead, Quality Operations & GMP Compliance will serve as the quality leader for the Princeton, NJ site, with direct responsibility for Quality Operations (QO) and overall accountability for site GMP compliance. This role provides quality oversight of GMP execution within Technical Operations, ensuring robust quality engagement and compliance across the full product lifecycle. Acting as the site's primary quality representative to regulators, clients, and senior leadership, this leader will champion a proactive culture of quality, transparency, and operational excellence.Key ResponsibilitiesSite Quality Leadership & Compliance• Ensure site-wide GMP compliance and product quality at the Princeton, NJ facility• Oversee GMP execution across Technical Operations, supply chain, and support functions with appropriate process controls• Partner with site and quality leadership to maintain a phase-appropriate, risk-based Quality Management System (QMS)• Serve as site lead during regulatory inspections and client audits, ensuring preparedness, clear communication, and successful outcomesDirect Leadership of Quality Operations• Lead and develop the Quality Operations team, including on-the-floor oversight, product disposition, deviations/CAPA, and document control• Oversee compliant handling and disposition of raw materials, apheresis materials, and final product• Provide guidance on New Product Introductions and technical transfers, ensuring phase-appropriate quality standards• Maintain a strong QO presence in GMP suites, warehouses, supply chain operations, and QC labs, driving real-time engagement• Oversee batch record review, lot disposition, product release, and shipping• Collaborate with Manufacturing and QC for timely release of materials, in-process controls, and final products• Implement a best-in-class on-the-floor quality program, reinforcing training and compliance• Ensure QC labs meet GMP standards, overseeing testing, equipment qualification, and material handlingClient Support• Act as senior quality representative for client programs, ensuring regulatory alignment and on-time deliverables• Lead and host client audits for the Princeton site, managing project-specific documentation• Provide quality leadership in technical transfers and cross-site initiativesLeadership & Collaboration• Mentor and develop the QO team, fostering accountability, growth, and a culture of excellence• Collaborate with senior leadership and cross-functional teams to align quality and compliance initiatives• Oversee staff scheduling, training, and performance management• Promote a culture of quality, compliance, and operational excellenceRequired Qualifications• B.S. or M.S. in Life Sciences, Engineering, or related field• 10-15+ years of progressive quality leadership experience in cell therapy, biotech, or biologics operations, with significant time in GMP environments• Strong expertise in cell therapy or ATMP manufacturing, with in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW)• Proven track record in a CDMO setting, balancing multiple client programs and compliance expectations• Demonstrated success leading QA operations with oversight of manufacturing and technical operations• Experience preparing for and leading regulatory inspections, client audits, and internal audits• In-depth knowledge of aseptic manufacturing and cell therapy modalities (CAR-T, NK, iPSC, TILs)• Excellent communication, collaboration, and negotiation skills• Strong leadership skills with proven ability to develop teams• Ability to thrive in dynamic environments, manage competing priorities, and resolve complex quality issues• Flexibility to work evenings, weekends, or shifts as operational needs dictate• Strong organizational skills with a positive, solution-oriented attitudePreferred Qualifications• Experience driving continuous improvement initiatives in a growing organization• Ability to adapt and innovate best practices in a fast-paced environment• Familiarity with clinical-to-commercial transitions for cell and gene therapiesPhysical Requirements• Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations• Flexibility to work in various environments, including gowning for a CNC/ISO7-8 facility• Ability to lift up to 25 lbs.• Ability to perform physical tasks such as bending, standing, and working with cell-based products or chemicalsWork Schedule• Standard business hours with flexibility required, including evenings, weekends, and shift-based schedules as operational needs dictate• Primary location: Princeton, NJ facility, with travel to the Newark, NJ facility as needed based on business demands

Created: 2025-10-02