Senior Specialist Quality Assurance, CSV
Benefits
Unlimited PTO
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Role Overview:
- The Senior Specialist Quality Assurance, CSV is responsible for ensuring GxP systems are compliant with regulatory and quality standards.
- This role partners with IT and business teams to support system lifecycle activities and validation processes.
Key Responsibilities:
- Provide quality oversight for computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards.
- Serve as QA CSV SME during vendor evaluations, software implementation, and qualification of GxP systems.
- Lead investigations for CSV-related deviations, system failures, and data integrity issues.
Qualifications:
- 7+ years in pharmaceutical/biotech space, 5+ years CSV validation lifecycle management.
- Excellent understanding of 21 CFR Part 11/Annex 11, CSV, CSA, SDLC, GDPR, and GAMP 5.
- Experience validating AI/ML-based systems in a regulated environment.
What We Offer:
- 100% paid health benefits including Medical, Dental, and Vision.
- 401(k) program with company match and flexible time off.
- Generous parental leave and additional fringe perks.
Definium Therapeutics
Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-based treatments for psychiatric and neurological disorders. The company is publicly traded on Nasdaq and focuses on scientific rigor to create accessible mental health treatments.