Product Development Quality Manager Jobs in Oregon

See Yourself at Telix

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.

Education and Experience:

• 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