CSV (Computer Systems Validation) Manager

DESCRIPTION

REQUIRED EXPERIENCE AND QUALIFICATION

• Minimum Bachelor's Degree or its equivalent in Life Sciences, Computer Science, Engineering, Pharmacy, or a closely related discipline
• Minimum of 7–9 years of hands-on experience leading Computer System Validation within a regulated GxP environment
• Minimum of 2 years of formal people management or team leadership experience
• Demonstrated experience serving as a validation SME during client audits or regulatory inspections, with a proven track record of authoring and approving complex validation packages across multiple concurrent systems.

REQUIRED SKILLS

• Comprehensive, expert-level knowledge of CSV/CSA methodologies, SDLC frameworks, eClinical technologies, and clinical development study documentation within a regulated Life Sciences environment
• Proven ability to independently author, critically review, and formally approve the full suite of validation deliverables across multiple concurrent programs, including experience directing CAPA management, deviation investigations, and root cause analyses in a GxP-regulated context
• Demonstrated ability to lead and develop technical teams in a compliance-driven environment, with a clear capacity to set expectations, delegate effectively, and maintain uncompromising quality standards
• Strong client management and stakeholder engagement skills, with the ability to navigate complex relationships and represent the organization with diplomacy, technical authority, and sound professional judgment
• Mastery-level proficiency in English (CEFR C2), with exceptional technical writing ability and a proven track record of producing validation documentation and compliance communications that are precise, logically structured, and entirely unambiguous
• Superior ability to articulate complex regulatory and scientific concepts with clarity and authority to diverse audiences (including executives, clients, regulatory bodies, and cross-functional teams), whether in writing or in person
• Advanced proficiency in Microsoft Office Suite and working familiarity with electronic Quality Management Systems (eQMS), document management platforms, and software development tools.
• Superior organizational skills and the ability to manage competing priorities without compromising quality.