Director, Quality Assurance - Trenton, United States - Perspective Therapeutics

Description

The Director, Quality Assurance oversees Perspective Therapeutics' (PTX) Somerset, New Jersey Quality Management System (QMS) and ensures that the system and Somerset site operation are compliant with applicable regulations, standards and company requirements.

This leader provides direct management to the Somerset Quality Team (Quality Assurance and Quality Control) and supports the site leadership team, as well as the company Quality Leadership Team in the maintenance, expansion and improvement of PTX's Quality systems and strategic objectives.

This position will champion the efforts to foster a quality culture of continuous improvement and ensure that PTX management is apprised of site quality performance, improvement needs and dynamic regulatory and business quality requirements.

This individual will analyze business and/or technical opportunities for PTX with regards to radiopharmaceutical and aseptic product quality requirements.

Objective

The Director, Quality Assurance oversees Perspective Therapeutics' (PTX) Somerset, New Jersey Quality Management System (QMS) and ensures that the system and Somerset site operation are compliant with applicable regulations, standards and company requirements.

This leader provides direct management to the Somerset Quality Team (Quality Assurance and Quality Control) and supports the site leadership team, as well as the company Quality Leadership Team in the maintenance, expansion and improvement of PTX's Quality systems and strategic objectives.

This position will champion the efforts to foster a quality culture of continuous improvement and ensure that PTX management is apprised of site quality performance, improvement needs and dynamic regulatory and business quality requirements.

This individual will analyze business and/or technical opportunities for PTX with regards to radiopharmaceutical and aseptic product quality requirements.
Essential Functions

Represent PTX internally and externally on quality matters (includes interactions with regulatory bodies, vendors, third party partners, and customers as well as PTX colleagues).

Provide guidance and support to enhance a quality culture of continuous improvement and safety across the organization through further clinical development and commercialization of radiopharmaceutical products.

Manage Quality Assurance and Quality Control personnel, utilizing previous leadership and coaching experience in the pharmaceutical industry.

Oversee staff selection, performance, development, and training processes to ensure team competencies, capabilities and capacity to reach the business goals and expectations.

Act in a cross-functional role with Production, Safety, Clinical, R&D, Operations, Project Management, and other functional areas, ensuring compliance to the applicable regulations for the maintenance and enhancement of PTX's products, projects, budget and facilities.

Oversee batch release process to ensure products are produced according to all applicable regulations, standards and procedures.
Ensure the proper performance of PTX's QMS, including site quality audit program.
Demonstrate skills at connecting with people, communicating effectively, and building relationships at all organizational levels.
Ensure annual GxP training requirements are met (including GMP, GCP, GDP, and GLP).

Provide oversight of product and process investigations, deviations, and CAPA management to ensure timely resolution of issues and prevention of recurrence.

Track and trend internal and external manufacturing quality data; report metrics to staff and management at scheduled intervals to track performance and initiate improvements.

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.

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

A bachelor's degree (or higher) in scientific discipline is required.
Minimum of 10 years' applicable experience with Radiopharmaceuticals/Pharmaceuticals in a Quality role, with 5 years leading teams.
Experience in oversight of sterile drug development/manufacture, preferably aseptic products.
Experience in interpreting and applying regulatory requirements applicable to Radiopharmaceuticals.
Experience in hosting and responding to regulatory audits.
Understanding of manufacturing license requirements in New Jersey.

Knowledge / Skills / Ability

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.
Ability to make decisions, act on them and accept accountability for outcome of decisions.
Ability to work under pressure and multi-task; flexibility to handle a variety of projects and shifting priorities.
Ability to research, interpret, understand and explain requirements of future business growth opportunities.
Excellent problem solving, investigations, interpersonal and communication (oral 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.
Ability to identify, communicate and mitigate operational risks.
Ability to travel up to 10%.
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.

For information on Perspective Therapeutics, visit our website at:

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