Sr. Manager, Quality

Sr. Manager, Quality

We are seeking a Sr. Manager to serve as the site Quality leader who supports and helps execute Perspective Therapeutics' Somerset, NJ Quality Management System (QMS), with primary accountability for site-level quality performance, ensuring that the system and site operations are compliant with applicable regulations, standards, and company requirements. This experienced people leader and subject matter expert provides day-to-day leadership to the Somerset Quality Team (Quality Assurance, Quality Control, and Microbiology), sets quality priorities and direction for the site, partners with site leadership, and supports the Quality Leadership Team in achieving near- and long-term strategic objectives aligned with quality requirements.

The Sr. Manager, Quality champions a sustainable quality culture of continuous improvement, ensures senior management and corporate Quality leadership are informed of site quality performance, risks, and improvement needs, and applies sound judgment and practical, on-the-floor problem solving to support safe, compliant manufacturing. This individual proactively assesses and manages quality and compliance risks, particularly those related to radiopharmaceutical and aseptic product requirements and drives timely, effective, and durable corrective and preventative actions.

• Serve as the primary site Quality representative and decision-maker on routine quality matters, representing Perspective Therapeutics in interactions with suppliers, third-party partners, and internal stakeholders; independently resolves issues within delegated authority and escalate risks appropriately (may support regulatory interactions as needed).
• Provide visible leadership and strategic guidance to strengthen a quality culture of continuous improvement and safety across the organization through further clinical development and commercialization of radiopharmaceutical products.
• Direct, mentor, and develop Quality Assurance, Quality Control, and Microbiology staff through hands-on coaching, clear performance expectations, succession planning, and active presence in operations.
• Support hiring, onboarding, training, and performance management processes to ensure team competencies, capabilities, and capacity to meet business goals and expectations.
• Partner cross-functionally with Production, Safety, R&D, Operations, Program Management, and other functional areas to ensure compliant execution of procedures, robust documentation practices, and effective resolution of quality issues.
• Oversee batch release process, ensuring products are manufactured and tested in accordance with all applicable regulations, standards and procedures.
• Ensure the proper performance of Perspective Therapeutics' QMS, including site quality audit program and follow-up of audit outcomes.
• Demonstrate management-level communication skills, with the ability to influence, align, and build trust across all organizational levels.
• Maintain availability to work outside of regular business hours and provide on-site and/or remote support for night shift operations on an as-needed basis.
• Ensure annual GxP training requirements are met (including GMP, GCP, GDP, and GLP) and assess the effectiveness of training programs.
• Provide oversight of product and process investigations, deviations, and CAPA management to ensure timely resolution of issues and prevention of recurrence.
• Own site-level metrics and performance monitoring, including tracking and trending internal and external manufacturing quality data; interpret trends, present insights to management, and drive improvement initiatives.
• Establish testing protocols and ensure all third-party testing is conducted in a timely manner at qualified vendors and according to approved protocols.
• Maintain facility licenses and registrations for manufacturing requirements.

• A bachelor's degree (or higher) in scientific discipline is required.
• Minimum of 7 years' applicable experience with Radiopharmaceuticals/Pharmaceuticals in a Quality role, with at least 3 years in a supervisory and/or site quality leadership capacity.
• Experience in oversight of sterile drug development/manufacture, preferably aseptic products.
• Experience in interpreting and applying regulatory requirements applicable to Radiopharmaceuticals preferred.
• Demonstrated experience serving as a quality lead for a manufacturing site, program, or major functional area.
• Experience in hosting and responding to regulatory audits.
• Comprehensive knowledge of manufacturing license regulations in New Jersey.

• Strong knowledge of 21 CFR Parts 11, 58, 210, 211, 212, 312, EU GMP (Annex
  1) and others.
• Strong knowledge of ICH guidelines and aseptic practices.
• Knowledge of global regulatory requirements, including PIC/S.
• Knowledge of radiation diagnostic and therapy products.
• Strong knowledge of regulatory requirements for US, EU, and other global markets.
• Proven ability to exercise independent judgment, make…