CSV & Regulatory Compliance Specialist

About the Role:

We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards.

Key Responsibilities:

• Lead and execute Computer System Validation (CSV) activities across various GxP-regulated systems and applications.
• Ensure all software, cloud platforms, and supporting infrastructure comply with GAMP 5 guidelines and 21 CFR Part 11 requirements.
• Develop and maintain validation documentation including:
• Validation Plans (VMPs)
• User Requirements Specifications (URS)
• Functional Specifications
• Risk Assessments
• IQ/OQ/PQ Protocols and Reports
• Traceability Matrices
• Collaborate with IT, Quality Assurance, Development, and Business teams to define validation scope and strategies.
• Support audits and inspections by providing evidence of validation and compliance.
• Perform periodic reviews and revalidations as required by change control or system lifecycle stages.
• Provide training and guidance to internal teams on CSV best practices and compliance requirements.
• Ensure data integrity principles are embedded across systems and processes.
• Maintain awareness of evolving regulations and best practices related to computerized system validation.

Required Qualifications:

• Minimum 10 years of experience in CSV within regulated industries (life sciences, healthcare, pharma, etc.)
• Deep understanding of GxP, GAMP 5, 21 CFR Part 11, and data integrity principles
• Demonstrated experience validating a variety of systems (e.g., LIMS, ERP, eQMS, cloud platforms, SaaS)
• Strong technical writing skills and attention to detail for documentation
• Experience supporting audits by FDA, EMA, or other regulatory bodies
• Ability to lead validation projects independently from planning through execution and closure
• Familiarity with change control, CAPA, and deviation management in regulated environments
• Excellent communication, collaboration, and project management skills

Preferred Qualifications:

• Certifications in CSV, GAMP 5, or related regulatory compliance programs
• Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, or related field
• Experience working in Agile/DevOps environments while ensuring compliance
• Familiarity with cloud platforms (e.g., AWS, Azure) and their validation in a regulated context