Manager, Quality Management System

Develop, manage, and maintain continual improvement of QA programs, policies and procedures for pre-clinical, clinical, and commercial radiopharmaceutical drug production. Maintain oversight of the QA program and QMS at a single manufacturing facility producing products under 21 CFR Part 210, 211, and 212 regulations. Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance. Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Engineering and Operations team. Write, review, approve, and/or implement quality procedures, specifications, processes, and methods as required. Oversee and manage the Change Control process to ensure changes are implemented according to applicable regulations and internal procedures. Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications. Prepare and present periodic review of the quality system for regular Management Review Final review and approval of batches for release and/or recall Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. Development, review, and approval of facility, process, and equipment validations Ensure that team members are properly trained and qualified and that training tracking and documentation is accurate and maintained in a timely manner. Ensure continuous development and training of the QA team to maintain a high level of compliance and quality standards. Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site. Liaise with internal and external inspectors and representatives, particularly on QA related topics. Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.). Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify management problems in personnel, equipment, and the facility that require correction. Review documents associated with the site s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality. Ensure the qualification and ongoing performance of critical suppliers and vendors, including conducting periodic audits and reviewing quality agreements. Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement. Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations. Implement risk management processes to proactively identify and mitigate potential quality and compliance issues. Ensure any deviations from normal procedures are documented and justified. Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain CAPA, deviation, and OOS protocols). Develop and monitor key quality metrics (e.g., CAPA, audit findings, deviations) and report trends to senior management, recommending corrective actions where needed. Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 210, 211, and 212 requirements. Ensure product complaints are managed in a manner consistent with SOPs and FDA regulations. Attend quality and operational meetings. Interface with QA and Operations on quality-related issues. Provide status updates as required management. Act as the primary contact during regulatory audits/inspection , providing documentation and explanations as required. Other responsibilities as required.