Director, 211 Manufacturing Quality and Regulatory Affairs

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

Remote Position - West Coast and Rocky Mountain Region Preferred

Role: Director, 211 Manufacturing Quality and Regulatory

Reports to: VP, Quality and Regulatory Starting Salary - &190,000+ (Bonus Eligible)

Remote Position - West Coast and Rocky Mountain Region Preferred

The Director, 211 Manufacturing Quality & Regulatory Affairs is responsible for providing enterprise Quality and Regulatory governance for U.S. operations, facilities, projects, and client programs subject to 21 CFR Parts 210 and 211.

The Director provides Quality Unit leadership and oversight of the Quality Management System, regulatory compliance, inspection readiness, quality risk management, and continuous improvement activities supporting the development, technology transfer, manufacturing, testing, and release of therapeutic radiopharmaceutical products. This position serves as a subject matter expert in pharmaceuticals, ensuring compliance with FDA regulations, current Good Manufacturing Practices (cGMP), USP standards and all applicable federal and state regulations. The Director partners closely with internal and external stakeholders to ensure product quality, regulatory compliance, operational excellence, and client satisfaction.

Essential Duties & Responsibilities

* Provide Quality and Regulatory governance for all US facilities, projects, technology transfers, client programs, and manufacturing activities operating under 21 CFR Parts 210 and 211. Serve as the primary Quality and Regulatory point of contact for all 211 facilities, providing leadership, guidance, escalation sup