Director, Computer System Validation/Assurance

Work Schedule

Environmental Conditions

Job Description

Location:

India

Department:

IT CoE

Reports To:

IT CoE Sr. Director

Thermo Fisher Scientific is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are speeding up life sciences research, solving sophisticated analytical issues, improving efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to assist them!

Thermo Fisher’s 4i Values of Integrity, Intensity, Innovation, and Involvement make up our culture and guide our employees’ interactions – with our customers, suppliers, and partners, and with each other. These four values are the very foundation of our culture and are fundamental to our continued growth. We are an equal opportunity employer.

Our distributed team offers an unmatched mix of brand new technologies, purchasing convenience, and pharmaceutical services across our top-tier brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Thermo Fisher Scientific India is certified by GPTW for building a High-Trust, High-Performance Culture™ that strengthens our position as one of the world's most admired companies and takes us a step closer to achieving our 2030 Vision. Amidst the evolving economic environment, this certification for the consecutive 6th year is truly a reflection of our commitment to providing equal opportunity, embracing diversity, and fostering a culture that empowers our colleagues to make meaningful contributions and build exciting careers!

Position Summary:

The Director of Computer System Validation/Assurance (CSV/CSA) is responsible for the comprehensive leadership, strategy, execution, and governance of all validation activities related to computerized systems supporting GxP-regulated operations across the pharmaceutical CDMO environment. This role integrates regulatory compliance (21 CFR Part 11, EU Annex 11), GAMP 5 guidelines, ITIL service management practices, and DevOps-based automation frameworks to ensure systems are validated, auditable,

secure, and continuously improving as part of continual improvement to build a strong framework. This role will supervise a team across different global locations, working closely with IT, QA, regulatory, and operations groups, and acting as a key SME for internal customers and external auditors.

Key Responsibilities:

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 (e.g., 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 (e.g., 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 (e.g., 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.