Director of Quality Assurance & Control

Eckert & Ziegler Radiopharma Inc•Wilmington, MA

86d•$130,000 - $180,000•Onsite

About The Position

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 an opportunity to shape and strengthen Quality during a critical phase of growth in one of the most dynamic sectors of modern medicine. 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. 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.

Requirements

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

Nice To Haves

Experience supporting facility expansion or manufacturing build-outs strongly preferred
Radiopharmaceutical experience preferred

Responsibilities

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
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
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