Senior Manager, Computer System Validation (CSV)

Senior Manager, Computer System Validation (CSV)

W2 Contract

Pay Rate: $70 - $90 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

We are seeking a highly experienced and strategic Senior Manager, Computer System Validation (CSV), to join our IS Quality team. This role will lead validation efforts for GxP-relevant computerized systems, ensuring compliance, inspection readiness, and alignment with regulatory expectations and industry best practices. This individual will serve as a key cross-functional partner across Information Sciences (IS), Quality Assurance (QA), and business stakeholders, driving validation strategy, execution, and continuous improvement initiatives across enterprise systems.

Duties and Responsibilities:

• Lead validation strategy and execution for GxP computerized systems across their lifecycle.
• Partner with IS, QA, business teams, and vendors to implement and validate new systems and manage changes to existing systems.
• Author, review, and approve validation documentation, including risk assessments, validation plans, test protocols, and reports.
• Ensure compliance with applicable regulatory requirements and industry standards, including FDA 21 CFR Part 11, 21 CFR 820.70(i), EU Annex 11, ICH E6 (R2), and GAMP 5.
• Drive risk-based validation approaches aligned with CSA (Computer Software Assurance) principles.
• Maintain system validation state, ensuring continuous inspection readiness.
• Lead deviation, CAPA, and remediation activities related to CSV.
• Support system periodic reviews, including user access and audit trail reviews.
• Contribute to the development and continuous improvement of CSV procedures, templates, and standards.
• Support internal and external audits and regulatory inspections.
• Ensure data integrity principles and controls are implemented effectively.
• Provide leadership and mentorship on CSV best practices across the organization.

Requirements and Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in GxP Computer System Validation within pharmaceutical or biotechnology environments.
• Deep expertise in GxP regulations, including 21 CFR Part 11, Annex 11, and GAMP 5.
• Strong understanding of CSV/CSA methodologies and system lifecycle processes.
• Experience with cloud-based/SaaS systems validation.
• Demonstrated ability to manage multiple complex validation projects.
• Proven experience supporting regulatory inspections and audits.
• Strong stakeholder management and influencing skills.
• Excellent written and verbal communication skills.
• close attention to detail and commitment to quality.

Preferred Qualifications:

• Experience with platforms such as Veeva, Oracle Argus, TraceLink, or Trial Interactive.
• Familiarity with electronic document management and e-signature systems (e.g., Veeva QualityDocs, Egnyte GxP, DocuSign Part 11).
• Knowledge of IT security frameworks (NIST, ISO 27001, SOC 2).
• Understanding of privacy regulations such as GDPR, CCPA, and HIPAA.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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