Manager, Systems & Computer Systems Validation
MedPharm LtdDurham, North Carolina, United States
Posted May 5, 2026
Full Time
About the Company
MedPharm Ltd is a leading CDMO specializing in the development and manufacturing of topical and transepithelial therapies. With over two decades of experience, they offer comprehensive services including formulation development, clinical trial supply manufacture, and high-potency capabilities. MedPharm stands out by combining cutting-edge research with deep regulatory expertise to deliver tailored solutions that ensure patient success worldwide.
Job Description
The Manager, Systems & Computer Systems Validation is responsible for overseeing the validation of scientific and quality applications, managing the Computer Systems Validation program, and ensuring compliance with GxP regulations.
Requirements
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related field
- 8+ years of IT experience in a GxP-regulated life sciences environment
- 3+ years of direct experience leading CSV activities
- Hands-on ownership of a Waters Empower environment
- Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, and ICH quality guidelines
- Experience authoring and approving validation documentation across multiple system types
- Experience managing application vendors and integrators
Benefits
- Medical, dental, and vision insurance
- Retirement plan
- Paid time off
- Stock options
