Associate Director, Quality & Compliance, you will own GMP quality execution for a commercial-scale sterile facility, build and scale QA/QC capabilities, and drive inspection readiness in a fast-moving, startup environment. You’ll partner closely with Manufacturing, Engineering, and Regulatory to ensure quality.

Seeking an individual that thrives building systems from the ground up, and  is comfortable making high-impact quality decisions.
Pay: 140k -160K

• Lead and scale QA and QC teams supporting sterile radiopharmaceutical manufacturing

• Own batch record review and release, ensuring speed, accuracy, and compliance

• Drive investigations, deviations, CAPAs, change control, and SOP execution

• Build KPIs that matter (Right First Time, batch cycle time, release timelines)

• Lead inspection readiness and serve as a primary quality voice during FDA and regulatory inspections

• Partner cross-functionally to solve real problems in real time

• Develop talent, manage resources, and continuously raise the quality bar

• A bias for action, accountability, and pragmatic GMP decision-making

• Build quality systems that support first-in-class cancer therapies

• Join a company where your impact is visible and immediate

• Work with a high-caliber, results-driven team

• Help define what “great” looks like as we scale

Qualifications:

• Bachelor’s degree in Chemistry, Engineering, or related technical field

• 8+ years of QA/QC experience in a regulated pharmaceutical environment

• 5+ years in a people-leadership role

• Strong background in sterile injectables (radiopharma experience a plus)

• Startup, scale-up, or high-growth manufacturing experience strongly preferred

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