GREAT OPPORTUNITY! 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.
Essential Functions
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).
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
The work environment characteristics described here are representative of those an employee encounters performing the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
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.
Essential Functions
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.
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
- 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 risk-based decisions, and accept accountability for outcomes.
- Ability to work under pressure and multi-task; flexibility to handle a variety of projects and shifting priorities.
- Availability to support off-shift operations (including night shift) on an as-needed basis.
- Ability to research, interpret, understand and explain requirements of future business growth opportunities.
- Excellent problem solving, investigations, interpersonal and communication (verbal and written) skills.
- Strong management skills with experience meeting tight timelines and preparing budgets.
- Strong leadership skills with the ability to positively motivate a team.
- Hands-on leadership style with the ability to be present in the manufacturing environment, coach in real time, and drive timely resolution of quality issues.
- Ability to identify, communicate and mitigate operational risks.
- Ability to travel up to 10%.
The work environment characteristics described here are representative of those an employee encounters performing the essential functions of this job. Reasonable accommodations may be made to 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.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.