Director, Quality

Perspective Therapeutics•Chicago, IL

21h

About The Position

The Director, Quality provides direct management to the Perspective Quality Team (Quality Assurance and Quality Control), managing the quality operation for the site start-up, and supports the site leadership teams, as well as the company Quality Leadership Team in the achievement of strategic objectives in alignment with quality requirements. The Director will champion the efforts to foster a quality culture of continuous improvement and ensure that Perspective Therapeutics’ 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 Perspective Therapeutics with regards to radiopharmaceutical and aseptic product quality requirements.

Requirements

A bachelor’s degree (or higher) in scientific discipline is required.
Minimum of 10 years’ applicable experience with Radiopharmaceuticals/Pharmaceuticals in a Quality Operations role, with 5 years leading teams.
Experience in oversight of sterile drug development/manufacture, preferably aseptic products, including clinical manufacture.
Experience in interpreting and applying regulatory requirements applicable to Radiopharmaceuticals preferred.
Experience in hosting and responding to regulatory audits.
Understanding of manufacturing license requirements in Illinois.
Strong knowledge of 21 CFR Parts 11, 58, 210, 211, 212, 312, EU GMP (including 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 data-driven 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 20%.

Responsibilities

Represent Perspective Therapeutics internally and externally on quality matters (includes interactions with regulatory bodies, suppliers, third party partners, and customers as well as colleagues at all organizational levels).
Lead Quality oversight of site start-up and facility readiness activities, including facility design review, quality risk assessments, and implementation of compliant Quality Management Systems (QMS) prior to GMP operations.
Develop quality strategies aligned with business goals, providing leadership and guidance to the quality team, ensuring cross-functional collaboration on quality issues, and managing high-level quality assurance activities across the company.
Oversee implementation and effectiveness of core QMS elements during site start-up, including document control, deviation management, CAPA, change control, training systems, supplier qualification, and internal audit programs.
Provide strategic planning support for Perspective Therapeutics new site operationalization in conjunction with cross-functional leadership and project teams.
Provide guidance and support to enhance a quality culture of continuous improvement and safety across the organization through further clinical development, logistics and commercialization of radiopharmaceutical products, and as a member of the Quality Leadership Team.
Manage Operational 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, Engineering, Project Management, and other functional areas, ensuring compliance to the applicable regulations for the maintenance and enhancement of Perspective Therapeutics’ 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 Perspective Therapeutics’ QMS, including site quality audit program and leading Quality Management Review.
Demonstrate skills at connecting with people, communicating effectively with data, 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.