Associate Director, Quality & Compliance

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
  
  

We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH