Computer System Validation Manager
Overview
Lead critical computer system validation initiatives supporting pharmaceutical and biotechnology operations in a hybrid role based in Redwood City, CA. As a Computer System Validation Manager, you will partner with Information Sciences, Quality Assurance, business owners, project teams, and vendors to plan and execute risk-based validation activities for new implementations and changes to existing GxP systems.
This role offers the opportunity to apply strong technical judgment across the system lifecycle, ensure data integrity and intended use, support inspection readiness, and guide multiple complex projects with minimal supervision. You will play a key role in validating cloud-based and SaaS platforms, assessing emerging AI capabilities, supporting data migrations, and strengthening CSV procedures and documentation.
Required Skills and Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.
- 10 or more years of GxP computer system validation experience in pharmaceutical or biotechnology environments.
- Substantial hands-on experience delivering validation projects.
- Strong knowledge of:
- GxP requirements
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Computerized system data integrity principles and controls
- Demonstrated ability to apply risk-based CSV methods and computer software assurance (CSA) principles across the system lifecycle.
- Knowledge of software development and lifecycle methodologies.
- Experience authoring, reviewing, and assessing validation documentation, including:
- Validation plans
- User requirements
- Functional and configuration specifications
- Risk assessments
- Test protocols
- Requirements traceability matrices
- Validation summary reports
- Experience executing or coordinating validation testing, documenting objective evidence, investigating discrepancies, and tracking issues through resolution.
- Experience supporting system implementations, change control, remediation, and software upgrades.
- Experience validating cloud-based SaaS systems and evaluating vendor documentation within a risk-based validation strategy.
- Experience working with study-level electronic systems, including:
- Electronic data capture (EDC)
- Interactive response technology (IRT)
- Pharmacovigilance (PV) databases
- Experience assessing electronic records and electronic signatures requirements.
- Experience assessing data integrity controls, including access management, audit trails, and electronic signatures.
- Ability to support CSV-related deviations, corrective and preventive actions (CAPAs), audits, regulatory inspections, and remediation activities.
- Ability to lead multiple complex projects with minimal supervision while meeting agreed timelines.
- Strong collaboration and communication skills, with the ability to work effectively with technical teams, QA, business stakeholders, vendors, and all levels of management.
- Strong attention to detail, documentation quality, and regulatory compliance.
Nice-to-Have Skills
- Experience working within a biopharmaceutical sponsor organization.
- Experience with quality, regulatory, clinical, or safety platforms such as Veeva, Oracle Argus, TraceLink, Trial Interactive, or Medidata.
- Experience with electronic document management and electronic signature systems, including Veeva QualityDocs, Egnyte GxP, or DocuSign configured for regulated use.
- Experience validating custom-developed GxP applications, including requirements definition, risk assessment, test development and execution, and ongoing validation through software changes.
- Experience assessing the GxP impact and risks of AI capabilities and systems.
- Familiarity with IT security frameworks such as NIST, ISO/IEC 27001, and SOC 2.
- Familiarity with privacy requirements such as GDPR, CCPA, and HIPAA.
- Experience developing or revising CSV procedures, forms, and templates.
- Experience supporting periodic reviews, system inventory updates, vendor assessments, and audit trail reviews.
- Experience validating data migrations, including migration planning and verification of data accuracy and completeness.
Preferred Education and Experience
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.
- 10 or more years of hands-on GxP computer system validation experience in pharmaceutical or biotechnology environments.
- Proven experience delivering validation programs for complex computerized systems throughout the system lifecycle.
- Demonstrated experience partnering with IS Quality, QA, business owners, vendors, and technical teams in regulated environments.
Other Requirements
- Work arrangement: Hybrid.
- Location: Redwood City, CA.
- Employment type: W2 only.
- Ability to manage multiple priorities and projects with minimal supervision.
- Ability to communicate project progress, risks, dependencies, and decisions to stakeholders.
- Ability to coordinate document reviews and approvals with system owners and Quality approvers.
- Ability to organize validation records for efficient retrieval and review.
- Availability to start as soon as possible.
