Associate Director, GCP Clinical Quality Assurance
LantheusMassachusetts, United States
Posted October 8, 2025
139000 - 232000 USD year
Full Time
About the Company
Lantheus Brand is a global leader in precision diagnostics and radiopharmaceutical oncology, leveraging over 65 years of scientific expertise to enhance patient outcomes. The company develops targeted therapeutics, advanced imaging agents, and AI‑driven solutions that empower clinicians to detect, treat, and monitor disease more effectively. Lantheus differentiates itself through its integrated, just‑in‑time manufacturing model and strategic partnerships that accelerate the delivery of high‑quality radiopharmaceuticals to the market. With headquarters in Massachusetts and a presence in Canada and Sweden, Lantheus combines deep scientific innovation with a patient‑centric culture that drives sustainable healthcare impact.
Job Description
Lantheus is seeking an Associate Director for GCP Clinical Quality Assurance. The role involves execution and performance of Lantheus CQA quality system elements, including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. The ideal candidate will have 7+ years of experience in the pharmaceutical or biotech industry with 5+ years in GCP Clinical Quality Assurance.
Requirements
- Bachelor’s degree in a scientific discipline
- 7+ years’ experience in the pharmaceutical or biotech industry
- 5+ years of experience in GCP Clinical Quality Assurance
- Proficient understanding of ICH GCP and applicable CFR regulations
- Experience providing GCP Clinical Quality Assurance guidance to Clinical teams for assigned Programs/Trials
- Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials
- Analytical and critical thinking skills
- Excellent communication (Oral and Written), planning, coordination, and time management skills
Benefits
- Comprehensive health benefits package
- 401(k) with company contribution
- Paid vacation, holidays, sick days, and paid parental leave
- Discretionary performance-based cash incentive
- Discretionary annual equity award