QA CSV Manager - GxP

Summary

Join Cerba Research's QA team as a QA Computer System Validation (CSV) Manager and take the lead in shaping quality and validation across a growing international organization. You will provide oversight and support for computerized systems, ensuring compliance with regulatory expectations and company requirements. This key position involves leading a small, experienced CSV QA team, directly influencing validation strategy, lifecycle documentation, and system compliance across multiple GxP environments. You will shape CSV strategy during a major QA transformation, ensure global regulatory compliance, and mentor your team to drive consistency and quality. The role requires a strong understanding of compliance and system validation in regulated environments and offers hybrid or remote options.

Requirements

• Responsible for QA review and approval of validation activities to ensure compliance with CSV and IT Regulations and guidance including FDA 21 CFR Part 11, EMA Guideline on computerized systems and electronic data in clinical trials, best practices such as GAMP 5, and internal policies and procedures
• Provide independent quality review and approval of system lifecycle validation documentation, such as plans, user requirements specifications, risk assessments, configuration documentation, protocols, and reports
• Quality review and approval of IT and automation system changes and periodic review status
• Ensure a consistent approach to qualification, change, and deviation management across systems
• Assist in driving validation project completion in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved, ensuring when appropriate that quality by design principles are incorporated into all validation design activities
• Support and approval of computerized systems investigations and deviations
• Participate in audits (internal and external) where required as quality specialist and/or SME
• Compliance with the Cerba Research Policies, Standard Operating Procedures, Work Instructions and other procedural documents relevant to the role
• Experience in QA IT/CSV in a GxP environment
• Knowledge of regulatory requirements relevant to the role including but not limited to Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and applicable legislation in Central and/or Specialty Lab (i.e. ISO guidelines)
• Quality Assurance background, mindset, and strong attention to detail
• Experience of the practical application of industry regulations and guidance documents for CSV, such as FDA 21 CFR Part 11, GCP E6, MHRA Data Integrity Guidance, GAMP5
• Fluent in English

Responsibilities

• Shape CSV strategy during a major QA transformation across newly integrated sites and systems
• Ensure global regulatory compliance by overseeing validation of critical GxP computerized systems
• Lead and mentor a skilled CSV QA team to drive consistency, quality, and stakeholder engagement
• Influence system design and change control by embedding quality early in the validation lifecycle

Benefits

Hybrid or Remote Options Available