• Associate Director, Quality & Compliance

    Astrix Technology (Indianapolis, IN)


    Associate Director, Quality & Compliance

     

    Quality Assurance

    Indianapolis, IN, US

    + Added - 15/12/2025

     

    Apply for Job

     

    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

    \#LI-RL1

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.