CSV (Computer Systems Validation) Manager

OVERVIEW:

The CSV (Computer Systems Validation) Manager Trial Interactive leads and advances TransPerfects global Life Sciences compliance initiatives including 21 CFR Part 11 GCP/ICH requirements and the companys ISO 9001-certified Quality Management System (QMS). The role holds direct accountability for the validation governance and continuous improvement of computerized systems using a risk-based approach ensuring that Trial Interactive platform solutions and related processes meet the highest standards of regulatory compliance client quality expectations and internal QMS requirements.

Operating at the intersection of technical authority regulatory strategy and people leadership the CSV Manager drives the maturity and scalability of the CSV function within the Trial Interactive division and provides senior-level support to other TransPerfect divisions as required. The role demands a consummate professional one who brings mastery-level command of the English language exceptional technical writing ability and the executive presence to represent the organization with credibility and precision in any regulatory or client-facing context. The CSV Manager directly leads a team of 23 CSV professionals setting the standard for quality accountability and continuous improvement across all validation activities.

DESCRIPTION:

• Lead and govern validation activities across the full Software Development Life Cycle (SDLC) including the validation of commercial off-the-shelf (COTS) systems qualification of third-party vendors and oversight of IT compliance activities such as infrastructure qualification disaster recovery testing backup and restore testing and vulnerability management

• Direct the drafting review and final approval of all validation deliverables (including validation plans and strategies requirement specifications risk assessments traceability matrices test protocols and scripts and validation summary reports) ensuring documentation is complete precise and fully compliant with applicable regulations and client quality standards

• Lead regulatory compliance assessments (e.g. 21 CFR Part 11 EU Annex 11) operational readiness reviews and system release validation activities translating findings into clear actionable outcomes across QA IT development and client-facing teams

• Govern change control processes and manage the periodic reviews and ongoing validation maintenance activities ensuring timely execution rigorous impact assessments and audit-ready reporting

• Lead investigations into validation-related incidents deviations and system issues; direct root cause analyses CAPA activities and client escalation reporting ensuring all outcomes are thorough defensible and resolved within established timelines

• Serving as the primary subject matter expert (SME) and point of escalation during client audits regulatory inspections and internal quality reviews

• Directly manage mentor and develop a team of CSV professionals providing structured guidance meaningful performance feedback and clear pathways for professional growth

• Drive process improvement initiatives within the Trial Interactive division including contributions to SOP development work instruction updates and QMS enhancement programs

• Complete all other tasks deemed appropriate for this role and assigned by senior leadership.

REQUIRED EXPERIENCE AND QUALIFICATION:

• Minimum Bachelors Degree or its equivalent in Life Sciences Computer Science Engineering Pharmacy or a closely related discipline

• Minimum of 79 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.