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# Manager, Computer Systems Validation (CSV)

- **Company:** Corcept Therapeutics
- **Location:** Redwood City, CA, United States
- **Experience:** Expert
- **Salary:** $160,600.0 - $189,000.0
- **Contract:** Permanent contract
- **Skills:** Clinical Trial Management Systems, Data Integrity, Data Migration, Electronic Signatures, Systems Development Life Cycle, Iq/oq/pq, Computerised Systems, Information Technology, Veeva, GXP
- **Published:** August 2, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=a6141d3d9d081f5a

## About the Role

* Thorough understanding of validation/qualification and concepts as it applies to pharmaceutical quality systems
 * Excellent communication skills with the ability to effectively communicate across organizational levels and functions
 * Proficiency with Veeva QualityDocs / QMS and ComplianceWire
 * Experience with CTMS and Regulatory systems
 * Ability to manage external software and consultant vendors

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 - $189,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

## Description

* Provide assessment/review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Systems)
 * Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies
 * Ensure compliance and the validated state of all GXP systems
 * Provide validation guidance on data migration activities as needed
 * Provide IT assessment and approval for GXP computer system changes
 * Develop and support testing of proposed changes in system development environments
 * Experience in authoring and managing documents such as change control, Risk Assessments, Validation Plans, User Requirements Specifications, Functional Specifications, qualification protocols (IQ/OQ/PQ), Traceability Matrix, system procedures, deviations and CAPAs
 * Coordinate and support vendor support release activities
 * Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including system enhancements, releases and revalidation
 * Responsible to manage external CSV consultants in CSV projects
 * Responsible as interface between IT and QA

Preferred Education and Experience:

 * 8+ years' experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment
 * Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 210, 211& 11, Annex 11, GAMP5, ICH Q9, Data Integrity, CSA


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