Quality Manager, Partners

Job Description | Quality Manager, Partners

Title | Quality Manager, Partners

Location | Open

Department | Quality/Regulatory/EH&S

Reports To | Director, Quality Management, Partners & Training

SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Director, Quality Assurance, Partners & Training, and provides Quality leadership to the Radiopharmaceutical Contract Manufacturing (RCM) division throughout the SOFIE network.

SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products.

This person will play an active and integral part of the Quality team supporting compliance, improvement, and implementation with all RCM products at all SOFIE facilities.

• Provide quality assurance support to the Radiopharmaceutical Contract Manufacturing (RCM) group within the SOFIE Network, including making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
• Be a quality liaison, develop solid relationships, and establish open communication with SOFIE partners and sponsors.
• Assist in the roll‑out of new products at SOFIE network sites.
• Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, and continue to establish an effective and efficient quality management system at one SOFIE facility, at minimum, and company wide.
• Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS).
• Assist Director, RCM, Directors, Quality Management, Directors, QA and Regional Managers, QA with quality initiatives, decisions, and training.
• Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA when necessary, closely track and follow‑up on these activities for timely closure, ensure that scientifically sound investigations are conducted and root causes are identified, initiate and implement CAPA plans, and evaluate effectiveness of the CAPA plans through reporting and trending.
• Author and review cGMP documents, including procedures, protocols, specifications, reports, records, and changes to these documents.
• Open change controls and initiate, maintain, and review SOFIE network and site‑specific procedures relative to their job functions.
• Assist with the ongoing training program and present training presentations on applicable job‑related procedures and topics.
• Identify non‑compliance problems and propose solutions as appropriate, interact effectively with other functional personnel at the site and corporate level, and resolve quality related issues.
• Initiate action plans to prevent cGMP non‑compliance and product quality problems proactively and ensure continuous and sustained improvements.
• Liaise with corporate QA for audits, customer audits, partner audits, and regulatory agency audits, perform readiness assessment and take corrective actions as needed prior to the audits, summarize and report auditing progresses daily, prepare complete responses to the audit outcomes on time, and ensure corrective actions are implemented according to the committed timelines.
• Review partner customer/patient complaints to determine the possible root causes, work with partners and customers to ensure concerns are addressed, quality standards are met, and issues are resolved promptly and effectively.
• Maintain knowledge of current regulations and quality policies, attend quality related meetings and conference calls, interface with corporate QA on quality related issues, and provide…