Senior Computer Systems Validation Lead - GMP/GxP Expert

RxCloud; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading healthcare technology company seeks a Computer Systems Validation Lead in San Francisco. This role requires over 10 years of experience with validation activities in GMP/GxP environments, and familiarity with regulatory documentation, including FDA 21 CFR Part 11. Ideal candidates will have a proven track record in developing validation documentation and experience with enterprise systems like SAP, Veeva, and Trackwise. Join our team to ensure compliance and support crucial validation strategies.

Qualifications

• 10+ years of experience in computer systems validation activities.
• 7+ years in GMP/GxP regulated environments.
• Experience with validation documentation and testing protocols.

Responsibilities

• Support and perform computer systems validation activities.
• Develop scalable validation strategies and documents.
• Conduct document reviews and ensure continuous compliance.

Skills

Computer systems validation

GMP/GxP experience

FDA 21 CFR Part 11

Documentation development

Test management tools

Tools

Microfocus ALM

ValGen

Veeva

Trackwise

Argus

Clinical systems

Quality systems

Job description

A leading healthcare technology company seeks a Computer Systems Validation Lead in San Francisco. This role requires over 10 years of experience with validation activities in GMP/GxP environments, and familiarity with regulatory documentation, including FDA 21 CFR Part 11. Ideal candidates will have a proven track record in developing validation documentation and experience with enterprise systems like SAP, Veeva, and Trackwise. Join our team to ensure compliance and support crucial validation strategies.