Computer System Validation Manager

DeWinter Group; Redwood City (CA); Hybrid; USD 170,000 - 210,000; Full time

Job summary

DeWinter Group in Redwood City, CA seeks a Computer System Validation Manager to lead CSV initiatives for pharmaceutical and biotech systems in a hybrid work setting. You will partner with IS, QA, business owners, and vendors to plan and execute risk-based validation for new implementations and changes to GxP systems.

This role emphasizes data integrity, inspection readiness, and guidance on cloud-based SaaS validation, with opportunities to influence validation strategy, documentation, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.
• 10+ years of GxP computer system validation experience in pharmaceutical or biotechnology environments.
• Hands-on experience delivering validation projects.
• Strong knowledge of GxP requirements, 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Experience authoring, reviewing, and assessing validation documentation (plans, URS, specs, test protocols, traceability matrices, summaries).
• Experience validating cloud-based SaaS systems and working with study-level electronic systems (EDC, IRT, PV).

Responsibilities

• Lead CSV initiatives in a hybrid role, coordinating with IS Quality, QA, and business stakeholders.
• Plan and execute risk-based validation activities for new implementations and changes.
• Validate cloud-based SaaS platforms and assess vendor documentation within a risk-based strategy.
• Develop and strengthen CSV procedures, forms, and templates; ensure inspection readiness.
• Support data migrations, deviations, CAPAs, audits, and regulatory inspections.
• Guide multiple complex projects with minimal supervision and on-time delivery.

Skills

GxP validation

21 CFR Part 11

EU Annex 11

GAMP 5

Risk-based CSV methods

Vendor coordination

Documentation & QA liaison

Cloud-based SaaS validation

Electronic records & signatures

Project leadership

Education

Bachelor's degree in Engineering/Life Sciences/CS or related field

Tools

Veeva

Oracle Argus

TraceLink

Medidata

Trial Interactive

Job description

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.