Director of Quality Assurance & Control

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Director of Quality Assurance & Control Full Time Eckert & Ziegler RadioPharma Inc, Wilmington, MA, US Salary Range: $170,000.00 To $200,000.00 Annually *This is an on-site role based in Wilmington, MA. We are seeking candidates who are already located within commuting distance; relocation support is not provided* Eckert & Ziegler Radiopharma, Inc. (EZRI) is expanding its U.S. radiopharmaceutical manufacturing and CMO operations in Wilmington, MA — including the build-out and qualification of a new Lu-177 production capability that will directly support advancements in targeted cancer therapies. We are seeking a highly capable, hands-on Director of Quality to lead QA, QC, validation oversight, and quality systems within a regulated cGMP environment. This is not a maintenance role. It is an opportunity to shape and strengthen Quality during a critical phase of growth in one of the most dynamic sectors of modern medicine. The Opportunity The Director of Quality Assurance & Control will report directly to the General Manager and serve as a key member of the site leadership team. This role partners closely with the Director of Site & CMO Operations, Radiation Safety Officer, QC Manager, and cross‑functional leaders to ensure compliant, coordinated execution of site priorities. This is a highly hands‑on leadership position. A visible, consistent presence on the manufacturing floor, in cleanrooms, and within daily operations is expected. The Director of Quality will actively engage with production, QC, and operations teams to ensure real‑time quality oversight and decision‑making — not operate solely from behind a desk. A major near‑term priority is supporting the Lu‑177 facility expansion from a quality standpoint, including equipment receipt, IQ/OQ/PQ oversight, cleanroom and facility qualification, and process validation. This role is ideal for a leader who thrives in growth environments and wants to build something meaningful — not simply inherit a static system. Key Responsibilities Quality Leadership & Operational Engagement Lead and manage site QA and QC functions Maintain and strengthen the site Quality Management System (QMS) Maintain strong, visible presence within manufacturing and laboratory operations Provide real‑time quality oversight and decision‑making support on the production floor Ensure compliance with FDA cGMP regulations (21 CFR Parts 210/211) and applicable regulatory standards Oversee deviation investigations, CAPA, change control, and risk management processes Ensure inspection readiness and lead regulatory and customer audits Partner with site leadership to align quality strategy with operational execution Equipment & Facility Qualification Provide quality oversight and approval of equipment qualification activities (IQ/OQ/PQ) Support qualification of Lu‑177 expansion areas, cleanrooms, utilities, and critical systems Review and approve qualification protocols and reports Ensure validation documentation meets regulatory expectations Partner cross‑functionally during equipment receipt, commissioning, and qualification to ensure compliant execution Process Validation & Sterile Manufacturing Oversight of process validation and continued process verification Ensure method validation and QC laboratory readiness Oversee batch record review and batch disposition release processes Provide quality oversight for isotope manufacturing and CMO operations Ensure compliance within sterile, cleanroom‑based manufacturing environments Monitor aseptic practices and environmental controls to ensure sustained compliance Qualifications Bachelor’s degree in a scientific discipline; advanced degree preferred 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing. Demonstrated QA/QC leadership experience in a cGMP‑regulated environment Direct experience supporting equipment qualification and process validation programs Strong experience in sterile manufacturing and cleanroom operations Strong working knowledge of FDA cGMP regulations and inspection readiness practices Experience supporting facility expansion or manufacturing build‑outs strongly preferred Radiopharmaceutical experience preferred EZRI offers a competitive benefits package designed to support our employees’ health, well‑being, and professional growth, including: 100% employer‑paid medical insurance for individual coverage Subsidized medical plans for dependents and families Dental and vision insurance 401(k) with generous company match 15 days of paid time off (PTO) plus company holidays Life and disability insurance Employee assistance program (EAP) Opportunities for training and career development Work Structure On‑site in Wilmington, MA Hands‑on, floor‑engaged leadership role Reports directly to the General Manager Serves as a core member of the site leadership team Why Join EZRI? Lead Quality during a transformative Lu‑177 manufacturing expansion Contribute directly to advancements in nuclear medicine and targeted cancer therapy Operate in a collaborative, mission‑driven environment where leadership is accessible and engaged Shape quality systems that support real growth — not just maintenance Competitive compensation, annual bonus eligibility, and comprehensive benefits If you are a cGMP Quality leader who values operational engagement, disciplined execution, and meaningful impact in healthcare, we welcome the opportunity to connect. #J-18808-Ljbffr Eckert & Ziegler Radiopharma Inc