[Hiring] Director, Product Development Quality @AMER

Role Description

As the Director, Product Development Quality, you will lead the Development Quality function, supporting radiopharmaceutical development programs from early clinical development through registration-readiness. This role carries direct accountability for leading and scaling a high-performing Development Quality team to support the organization’s strategic transition from PET diagnostics into radiopharmaceutical therapeutics. You will establish and govern QMS elements specific to development-stage programs, represent Quality at the leadership level, and serve as a primary Quality interface with regulatory agencies, CDMOs, and clinical supply partners. The ideal candidate is a seasoned quality leader with deep expertise in radiopharmaceutical GMP, development-stage quality experience, and the ability to lead cross-functional quality execution in a high-growth environment.

Key Accountabilities

• Good Manufacturing Practices (GMP)
  • Provide GMP quality oversight for development-stage radiopharmaceutical programs, including alignment with applicable ICH, FDA, EMA, PMDA, USP <821>, and relevant 10 CFR requirements governing radioactive drug substances and drug products.
  • Partner with cross-functional teams to apply fit-for-purpose GxP expectations for radiopharmaceutical development programs.
  • Support quality oversight for short half-life manufacturing considerations specific to radiopharmaceuticals, including real-time release testing (RTRT), compressed batch release timelines, and in-process control strategies.
  • Coordinate with technical teams and the Radiation Safety Officer, as appropriate, on quality interfaces related to hot-cell qualification, dose calibrator validation, and radiation safety program requirements.
• Development Quality and Clinical Supply Oversight
  • Provide Development Quality input and oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content.
  • Support quality activities related to clinical investigational medicinal product supply, including CDMO oversight, comparator sourcing, clinical packaging, labeling, distribution, and release requirements.
  • Review and provide quality input on development program documentation, including manufacturing records, specifications, validation documentation, deviations, CAPAs, and change controls.
• Quality Systems and Process Improvement
  • Support the implementation and continuous improvement of Development Quality procedures, templates, and governance practices.
  • Ensure development-stage quality processes are appropriately documented, scalable, and aligned with enterprise Quality standards.
  • Partner with Quality leadership to identify gaps, assess risks, and recommend pragmatic solutions for development-stage programs.
• Cross-Functional Leadership and External Partner Oversight
  • Represent Development Quality in program team meetings, stage-gate discussions, and cross-functional governance forums.
  • Partner with Regulatory Affairs, CMC, Clinical Operations, Manufacturing, Supply Chain, and external partners to ensure quality risks are identified, escalated, and managed.
  • Provide quality oversight of contracted manufacturing, testing, packaging, and clinical supply partners supporting development programs.
• Regulatory Compliance & Inspection Readiness
  • Support regulatory agency interactions, inspections, and submission-related activities as the Development Quality representative.
  • Provide input on development quality risk assessments when regulatory or GMP requirements cannot be fully integrated.
  • Support inspection readiness activities for development-stage programs and external partners.
• People Leadership
  • Lead and develop Development Quality team members, including coaching, workload management, performance feedback, and capability building.
  • Support headcount planning and organizational capability development as the Development Quality function matures.
  • Promote consistent quality decision-making, documentation practices, and cross-functional collaboration.

Qualifications

• Advanced degree (MS, PharmD, PhD) in a relevant scientific discipline (Pharmacy, Chemistry, Radiochemistry, or related field) strongly preferred; bachelor’s degree with equivalent experience considered.
• 10+ years of progressive quality experience within the pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in development-stage GMP quality.
• 7+ years of leading and developing quality teams, including experience building greenfield or newly established quality functions.
• Direct experience in radiopharmaceutical quality required, including familiarity with short half-life manufacturing, real-time release testing, and USP <821> compliance; oncology or targeted therapy development quality experience preferred.
• Demonstrated experience with IND/CTA submissions, NDA/BLA quality strategy, and CTD Module 3 authorship or oversight; direct regulatory agency interaction experience (FDA, EMA, and/or PMDA) required.
• Comprehensive understanding of Good Manufacturing Practices (GMP) and regulatory requirements.
• Proven ability to work with cross-functional teams and maintain effective relationships with key business partners.
• Strong communication and educational skills to support GxP and regulatory knowledge across the organization.
• Experience in documentation practices and record-keeping, ensuring accuracy and compliance.

Key Capabilities

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.