Senior Director, GxP Systems
Zenas BioPharma(4 days ago)
About this role
Zenas BioPharma is seeking a senior IT leader to establish and oversee the company's GxP compliance and validation programs for computerized systems. The role involves building validation strategies, ensuring regulatory inspection readiness, managing vendor relationships, and collaborating with various internal teams in a fast-paced biotech environment.
Required Skills
- Validation
- CSV
- CSA
- GxP
- Regulatory
- Quality Assurance
- Risk Management
- Inspection Readiness
- Vendors
- Compliance
Qualifications
- Bachelor’s degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field
- 12+ years of experience in IT GxP compliance, validation, or IT governance within biotech or pharmaceutical industries
- Leadership experience at the Director level or above
About Zenas BioPharma
zenasbio.comZenas BioPharma is a biotechnology company focused on discovering and developing therapies for autoimmune and inflammatory diseases. Their stated mission is “Enabling patients with autoimmune diseases to reimagine life,” and they concentrate on finding I&I (inflammation & immunology) innovations. Zenas advances novel drug candidates through discovery and development with the goal of bringing new treatment options to patients and partnering across the biopharma ecosystem.
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