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Associate Director, GxP Electronic Systems Quality Assurance
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role
Lead the Global Quality Systems Monitoring & Excellence program within a late-stage oncology biopharma developing RAS‑targeted therapies, ensuring compliance, governance, and continuous improvement of QMS.
Responsibilities- oversee audit readiness, inspection support, KPI/KQI analysis, CAPA governance, critical issue management, process standardization, and digital quality initiatives using AI and data analytics;
- build and lead a high-performing team.
- Bachelor's in Life Sciences, Pharmacy, or related field;
- 10+ years in QA/QMS roles in biotech/pharma, with regulatory inspection experience;
- strong knowledge of FDA, EMA, ICH regulations;
- experience with eQMS (e.g., Veeva Vault);
- leadership and stakeholder management skills.
- experience supporting late‑stage clinical and commercial products;
- knowledge of digital transformation and analytics;
- certifications like ASQ CQA or RAC.
- focus on GxP compliance, regulatory inspection readiness, digital quality platforms, and leadership in a fast-paced, regulated environment.
onsite Redwood City, CA, with a salary range of $186K-$233K, commensurate with experience.
Position Requirements
10+ Years
work experience
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