Astrix · 1 day ago
Associate Director, Quality & Compliance
Indianapolis, IN
Full-time
Onsite
Lead/Staff, Director/Executive
$140K/yr - $160K/yr
8+ years expAstrix is a company focused on building and scaling quality assurance and compliance in a commercial-scale sterile facility. The Associate Director, Quality & Compliance will lead QA/QC teams, ensuring compliance and quality in sterile radiopharmaceutical manufacturing while driving inspection readiness and collaborating with cross-functional teams.
ConsultingInformation Technology
Responsibilities
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
Qualification
Required
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)
Preferred
Startup, scale-up, or high-growth manufacturing experience strongly preferred
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
H1B Sponsorship
Astrix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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