Director, Product Development Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Development Quality function, facilitating radiopharmaceutical development initiatives from the early clinical stages to registration readiness.

• Establish and manage Quality Management System (QMS) components tailored to development-phase programs.

• Act as the Quality representative at the leadership level, serving as a primary liaison with regulatory agencies, CDMOs, and clinical supply partners.

• Deliver GMP quality oversight for radiopharmaceutical initiatives in the development phase.

• Collaborate with cross-functional teams to implement appropriate GxP expectations for radiopharmaceutical development projects.

• Provide quality oversight for manufacturing considerations related to short half-life radiopharmaceuticals.

• Contribute Development Quality insights and oversight for IND/CTA submissions, clinical-stage GMP operations, and quality content for CTD Module 3.

• Assist in the execution and ongoing enhancement of Development Quality procedures, templates, and governance practices.

• Lead and nurture members of the Development Quality team, including coaching, managing workloads, providing performance feedback, and fostering capability development.

⛳️ Requirements

• An advanced degree (MS, PharmD, PhD) in a relevant scientific discipline is highly preferred; a bachelor's degree with equivalent experience may be considered.

• A minimum of 10 years of progressive quality experience in the pharmaceutical, biotechnology, or radiopharmaceutical sectors, demonstrating expertise in development-phase GMP quality.

• At least 7 years of experience in leading and developing quality teams, including experience in establishing new or greenfield quality functions.

• Direct experience in radiopharmaceutical quality is essential, with familiarity in short half-life manufacturing, real-time release testing, and USP compliance; experience in oncology or targeted therapy development quality is preferred.

• Proven experience with IND/CTA submissions, NDA/BLA quality strategy, and oversight or authorship of CTD Module 3; direct interaction with regulatory agencies (FDA, EMA, and/or PMDA) is required.

• A thorough understanding of Good Manufacturing Practices (GMP) and regulatory guidelines.

• Demonstrated ability to collaborate with cross-functional teams and maintain effective relationships with key business partners.

• Excellent communication and educational skills to promote GxP and regulatory knowledge throughout the organization.

• Experience in documentation practices and record-keeping, ensuring accuracy and compliance.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development