Rx Group · 2 weeks ago
Quality Site Head
New Jersey, United States
Full-time
Onsite
Director/Executive
10+ years expRx Group is supporting a leading CDMO in recruiting a hands-on Quality leader to serve as Site Quality Head for a growing advanced therapy manufacturing site. This role oversees all aspects of Quality Operations and GMP compliance, acting as the site’s primary quality representative to internal teams, external clients, and health authorities.
Human ResourcesRecruitingStaffing Agency
Hiring Manager
Hemish Ilangaratne
Responsibilities
Serve as the Quality lead for the site, providing overall QA oversight and strategic direction for manufacturing operations
Act as the primary Quality contact for client audits and health authority inspections (FDA, EMA, etc.)
Represent the site in front-room interactions with clients, regulators, and senior leadership
Lead all aspects of shop-floor Quality Operations, including deviation management, batch/label control, document review, product release, and floor oversight
Ensure GMP activities are executed in compliance with internal procedures, global standards, and regulatory expectations
Drive readiness for inspection at all times - ensure robust systems, documentation, and practices that demonstrate a compliant state of control
Oversee shift-based QA operations, ensuring 7-day coverage and consistent leadership presence
Manage and develop a growing team including QA managers, supervisors, and QA associates
Build capability through mentoring, training, and fostering a culture of accountability, calm decision-making, and collaboration
Partner closely with leadership at the Newark site to ensure consistent quality standards and resource alignment
Transition the site from start-up operations to a stable, mature state of GMP compliance
Identify gaps, implement sustainable process improvements, and strengthen site readiness for commercial manufacturing
Promote a mindset of continuous learning and practical problem-solving throughout the Quality organization
Qualification
Required
Bachelor's degree in a scientific discipline
10+ years of Quality Assurance experience in GMP manufacturing, ideally with experience leading QA Operations
Demonstrated success hosting FDA and client audits, including PAIs and commercial inspections
Hands-on, pragmatic leader comfortable in fast-paced, evolving environments
Strong interpersonal and communication skills - able to influence, listen, and stay calm under pressure
Ability to operate both strategically and tactically; willing to roll up sleeves when needed
Preferred
advanced degree
Previous site or department head experience in a biologics, cell therapy, or CDMO setting
Company
Rx Group
Rx Group is a staffing agency that specializes in biotech, pharmaceutical, and med-tech recruitment.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Hemish Ilangaratne
Founder
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