Lead Computer Systems Validation Manager – Pharma

Doist; Redwood City (CA); On-site; USD 161,000 - 189,000; Full time

Job summary

Corcept Therapeutics, headquartered in Redwood City, California, seeks a Manager, Computer Systems Validation (CSV) to lead IT Quality and Risk Management within the Quality Systems Technology team. You will define validation standards, guide business teams on lifecycle validation, and ensure GXP compliant systems across the organization.

Key responsibilities include developing validation strategies, authoring validation documents, overseeing data migration, change control, risk assessments, and

Qualifications

• 8+ years’ experience in QA or Validation in pharma/biotech environments.
• Solid knowledge of 21 CFR Part 11, GAMP5, ICH Q9, and Data Integrity.
• Experience with electronic Records/Electronic Signatures and validation docs.
• Excellent communication across organizational levels and functions.

Responsibilities

• Provide assessment/review/oversight for Enterprise/GXP computer systems validation.
• Develop validation strategies and author validation documents (VMP, data migration plans, protocols).
• Ensure the validated state of all GXP systems and guidance on data migration.
• Manage external CSV consultants and coordinate vendor release activities.
• Support IT/QA interface and cross-functional validation projects and revalidation.

Skills

Validation/Qualification concepts

Communication skills

Vendor management

Documentation

Tools

Veeva QualityDocs

QMS

ComplianceWire

CTMS

Job description

Corcept Therapeutics, headquartered in Redwood City, California, seeks a Manager, Computer Systems Validation (CSV) to lead IT Quality and Risk Management within the Quality Systems Technology team. You will define validation standards, guide business teams on lifecycle validation, and ensure GXP compliant systems across the organization.

Key responsibilities include developing validation strategies, authoring validation documents, overseeing data migration, change control, risk assessments, and