Objective
The Manager, Quality Assurance helps ensure the consistent production of safe, effective, and high-quality radiopharmaceutical products that meet regulatory requirements and industry standards at the site level. This involves overseeing all aspects of quality assurance throughout the manufacturing process in alignment with company objectives, including testing, documentation, and compliance with Good Manufacturing Practices (GMP) and other relevant regulations. Additionally, the Manager is responsible for implementing quality improvement initiatives, training staff, and facilitating communication between different departments to maintain and enhance the overall quality management system. Essential Functions Directs the day-to-day activities of the Quality Assurance team at the designated facility. Communicates aligned quality objectives and requirements to company management and co-workers with a goal to foster a company-wide culture of quality focus and compliance. Manages and executes a quality management program consistent with pharmaceutical manufacturer requirements for API starting material and finished drug products. Executes and enhances quality aspects of project-specific plans to support company goals. Participates in company initiatives to apply quality principles to procedures and standards. Reviews design specifications, procedures, and other technical documents to ensure GXP alignment with GXP requirements. Oversees Change Control for TPI processes subject to quality requirements. Develops personnel training related to quality and good manufacturing practices. Oversees implementation and training of the Quality Management System (QMS). Oversees batch record approval process and acts as responsible manager ensuring quality attributes of batch. Manages the audit program, including regular internal audits and a supplier audit program. Directs the resolution of findings and ensures proper follow-up. Signatory to Quality Agreements associated with Supply Agreements. Manages Corrective and Preventive Action (CAPA) program, Continuous Improvement initiatives, Risk Management, and Out-of-Specification Investigations. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education / Experience Bachelor's Degree in a science, health, or related field (e xtensive equivalent QA experience in a pharmaceutical discipline may be considered as a substitute for academic degree). At least 7 years of progressive experience in GxP, QA management or QA positions in a Pharmaceutical and/or Medical Device industry is required. Experience with manufacture of sterile products, with aseptic expertise preferred. In-depth knowledge of radiopharmaceutical manufacturing processes is preferred, with a proven track record of implementing and maintaining robust quality management systems. Experience in compliance with Current Good Manufacturing Practices for pharmaceuticals and FDA Part 210/211 is required, and experience with Good Clinical Practices preferred. Must have experience with CAPA, Root Cause Analysis, Continuous Improvement, and OOS investigations. Knowledge / Skill / Ability Understand the principles of radiation safety and apply worker safety considerations to procedures, with the guidance of Perspective radiation safety experts. Understanding of sterile drug manufacturing requirements. Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards. Excellent written, verbal and interpersonal communication skills, with proven ability to collaborate, communicate and manage well at all levels of the organization. Demonstrated ability to work independently, manage projects and lead change across the organization. Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities. commitment to continuous improvement to drive excellence in aseptic, radiopharmaceutical quality assurance practices. Commitment to continuous improvement to drive excellence in aseptic radiopharmaceutical quality assurance practices. Ability to facilitate meetings and discussions in person and virtually. Ability to travel up to 30%. Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants. Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed. Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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