Director, Product Development Quality
The Director, Product Development Quality is sought for a fast-growing precision medicine organization focused on cancer and rare diseases treatments. Key responsibilities include:
- Strategic oversight for development-stage quality operations
- Ensuring compliance, scalability, and effective execution across pharmaceutical and radiopharmaceutical programs
- Establishing quality frameworks and supporting regulatory activities
- Partnering with cross-functional teams to define and implement quality strategies
- Providing GMP quality oversight for development-stage programs
- Supporting clinical supply activities, including manufacturing partners, clinical packaging, labeling, distribution, release processes, and documentation review
- Reviewing and overseeing quality documentation, including manufacturing records, specifications, validation materials, deviations, CAPAs, and change controls
- Developing and improving Development Quality procedures, governance models, templates, and operational processes
- Representing Quality in program meetings, strategic discussions, and cross-functional governance forums
- Managing relationships with external manufacturing, testing, and clinical supply partners
- Leading, mentoring, and developing Quality team members
- Supporting regulatory inspections, agency interactions, and inspection readiness activities
Requirements include extensive pharmaceutical or biotechnology quality leadership experience, advanced degree in Pharmacy, Chemistry, Radiochemistry, or related fields, and 10+ years of progressive quality experience. Direct experience with radiopharmaceutical quality requirements, clinical development programs, and regulatory expectations is also essential.
Benefits include a competitive salary package with annual performance-based bonuses, equity-based incentives, remote and flexible work environments, generous vacation allowances, and comprehensive support for learning, professional development, and career growth. This role offers the opportunity to contribute to innovative precision medicine programs with global impact.
To apply, visit our website.