Director, Quality

About the role

Join a growing, commercial-stage radiopharmaceutical company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At the forefront of technological innovation, NorthStar leverages first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. This role offers exceptional career growth and professional development opportunities in a specialized, fast-growing field.

Responsibilities

• Help design, implement, and evolve quality systems, processes, procedures, and workflows suitable for an emerging and growing CDMO operation.
• Lead the development, authorship, and maintenance of SOPs, specifications, and templates with a “right-sized” startup mindset.
• Support selection, qualification, and lifecycle management of laboratory equipment, software, and analytical tools.
• Partner with Business Development, Facilities, Manufacturing, Engineering, and Analytical Development to identify gaps and implement practical solutions quickly.
• Ensure all activities comply with applicable cGMP requirements (FDA 21 CFR Parts 11, 210, and 211), data integrity expectations, and global regulatory standards.
• Lead or support investigations related to deviations, OOS/OOT results, and atypical events, driving timely and effective root cause analysis and CAPAs.
• Actively participate in audits and inspections, including facility readiness, inspection hosting, and response development.
• Maintain strong inspection readiness through disciplined documentation, training, and laboratory practices.
• Support method validation, verification, qualification, and transfer for radiopharmaceutical-specific test methods, including radiochemical purity, identity, and sterility/endotoxin testing.
• Work closely with Analytical Development to transition early-phase methods into routine QC use.
• Provide technical troubleshooting support for analytical methods, equipment issues, and data anomalies.
• Drive continuous improvement initiatives focused on efficiency, compliance, automation, and right-first-time execution.
• Contribute to QA, QC, and Validation strategies, including integrated software, process flows, laboratory expansion, equipment qualification, and lifecycle management aligned with company growth.
• Monitor industry trends, regulatory updates, and emerging technologies relevant to radiopharmaceutical quality.
• Support quality aspects of CDMO programs, including client onboarding, quality agreements, knowledge transfer, technical discussions, and program execution.
• Support the project management team, addressing testing approaches, timelines, deviations, and data questions.
• Support technology transfer activities from client or internal development programs into manufacturing and QC operations.
• Directly manage and mentor a growing quality team, leading by example in both technical execution and quality mindset.
• Train and coach analysts on cGMP expectations, data integrity, and phase-appropriate processes.
• Foster a collaborative, problem-solving culture well-suited for an emerging company.

Requirements

• Bachelor’s Degree in Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum ten (10) years of Quality experience in a cGMP pharmaceutical, biotech, or radiopharmaceutical manufacturing environment, with at least five (5) years of management experience; or equivalent combination of education and experience.
• Demonstrated experience working in small companies or startup environments, with a willingness to be hands-on.
• Experience with radiopharmaceuticals, nuclear medicine, or radioactive materials testing strongly preferred.
• Experience supporting manufacturing operations with tight timelines and rapid release requirements.
• Knowledge of International Society for Pharmaceutical Engineering (ISPE) standards preferred.
• Advanced degree and American Society of Quality (ASQ) certification are preferred.

Additional Information

The company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, or Optional Practical Training support) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.