Source Job

• Lead and scale the Computer System Validation capability across IT, defining validation strategy, operating model, and risk-based approach while building the CSV team.
• Author, review, and execute validation lifecycle deliverables including validation plans, requirements, risk assessments, and test protocols.
• Collaborate with Quality, IT, business owners, and vendors to translate compliance needs into practical, scalable validation strategies.

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.

• Lead CSV and compliance for capital projects involving computerized manufacturing and lab systems.
• Plan, execute, and approve validation lifecycle documentation per GxP and regulatory expectations.
• Provide expert guidance on risk-based validation, IQ/OQ/PQ, change control, CAPA, and data integrity.