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Responsibilities:
- Define and implement validation strategy, operating model, and standards across GxP technology portfolio.
- Build and mentor the CSV team, including hiring, onboarding, and development.
- Apply risk-based approach to determine validation scope and evidence requirements.
Qualifications:
- Bachelor's degree in engineering, computer science, or life sciences; significant experience in regulated biotech/pharma.
- Strong experience with CSV, CSA, quality systems, and data integrity principles.
- Knowledge of GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+.
Benefits:
- Annualized base salary $150,000 - $178,000 USD.
- Remote work with travel flexibility.
- Equal opportunity employer committed to diversity and inclusion.
Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. It is a lean and growing organization guided by core values of Trust, Ownership, Curiosity, and Results, with a commitment to diversity, equity, and inclusion.