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Director, Computer System Validation / Assurance

Director, Computer System Validation / Assurance

Thermo Fisher Scientifichyderabad, India
18 hours ago
Job description

Strategic Validation Leadership

  • Design, Develop and implement an inclusive CSV / CSA governance framework throughout the organization, integrating strategy, roadmap, performance indicators, and policies.
  • Develop a harmonized global approach to validation that addresses system lifecycle, data integrity, cybersecurity, and scalability.
  • Ensure full integration of CSA (Computer Software Assurance) methodology to focus validation on high-risk areas and reduce unnecessary testing.
  • Collaborate with global digital transformation teams to embed validation requirements into digital and cloud-first initiatives.

Validation Lifecycle & Compliance Oversight

  • Lead the complete lifecycle of GxP system validation : risk assessment, URS, FRS, configuration specs, traceability matrix, IQ / OQ / PQ protocols, and periodic review.
  • Lead all aspects of qualification and revalidation efforts for ERP (, SAP), LIMS, ELN, CDS, QMS, MES, and cloud-hosted GxP platforms.
  • Maintain a central repository of validated systems with metadata including validation status, ownership, audit history, and system risk level.
  • Implement robust change control processes aligned with validation maintenance and ensure audit trail and deviation management integrity.

    • ITIL-Based IT Governance & Service Management

  • Integrate ITIL standard methodologies within the CSV process, encompassing incident, change, asset, configuration, and release management.
  • Establish SLAs and OLAs between quality, IT, and system owners to define expectations for validated system support.
  • Ensure accurate CMDB (Configuration Management Database) entries for all validated systems and components.
  • Coordinate validation activities within ITSM platforms like ServiceNow, including automated change workflow approvals and e-signatures.

    • DevOps, Agile, and Automation Enablement

  • Embed validation controls in CI / CD pipelines through risk-based gating, automated test verification, and release readiness assessments.
  • Drive adoption of Infrastructure as Code (IaC), automated regression testing, and cloud- native validation patterns.
  • Define and implement reusable validation templates, scripted testing libraries, and version-controlled documentation (, Git).
  • Collaborate with DevOps engineers, IT security, and platform architects to enforce compliance guardrails without stalling innovation.

    • Audit, Inspection, and Data Integrity Readiness

  • Serve as the company’s SME for all GxP computerized systems during regulatory agency

    • inspections and third-party audits.

  • Ensure evidence is available for access management, audit trail reviews, electronic records / signatures, and configuration integrity.
  • Perform internal audits to evaluate system readiness, alignment with SOPs, and proactive identification of data integrity risks.
  • Lead remediation programs in response to audit observations including documentation updates, CAPA management, and training.

    • Collaborative Engagement & Training

  • Develop a global training curriculum for IT, QA, laboratory, and operations staff on validation, CSA, and data integrity.
  • Head communities of practice (CoPs) for CSV / CSA and system owners to foster alignment, learning, and sharing of standard processes.
  • Collaborate closely with vendors during implementation, qualification, and SaaS onboarding to build appropriate validation packages and contracts (, SLAs, Data Processing Agreements).

    • Team Leadership & Organizational Development

  • Lead and mentor a hard-working team of CSV engineers, business analysts, IT validation specialists, and project leads.
  • Set clear team objectives, career paths, and technical training plans aligned to both business and compliance priorities.
  • Create global and site-level capacity plans to support growth in validation demand and system deployment initiatives.

    • Continuous Improvement & Metrics

  • Define and front end aspects of critical metrics like cycle time for validation, trends in audit findings, usage of automation, and rate of defect leakage.
  • Establish and build CSA adoption achievements across product and system categories.
  • Regularly review system inventory, validation status, periodic review schedules, and CAPA closure efficiency to drive progress.

    • Qualifications :

    Education & Experience

  • Bachelor’s or Master’s degree in Life Sciences, Computer Science, Engineering, or related technical field.
  • 12–15+ years of experience in CSV, with at least 5 years in a global leadership role and global work culture
  • Extensive experience with GxP-regulated systems, including SaaS, hybrid cloud, and on- premise applications in the CDMO or biopharma sector.

    • Skills & Knowledge

  • Expert in GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA guidance.
  • Sophisticated understanding of ITIL, Agile methodologies, DevOps, CI / CD, IaC, and cloud- native architectures.
  • Showed strength in written and verbal communication, ability to influence and partner optimally.
  • Proficient in tools such as ServiceNow, Jira, Git, Confluence, Azure DevOps, and electronic validation platforms.

    • Preferred Qualifications :

  • PMP, ITIL v4, GAMP Practitioner, or CSA credential preferred.
  • Experience in regulated product launches supported by validated systems.
  • Familiarity with AI / ML model validation or GxP automation analytics frameworks.
  • Background in global quality systems integration, cloud qualification, and third-party SaaS risk management would be an advantage

    • We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

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