Job description
Description
QA CSV Manager
Location(s) – Belgium, the Netherlands or United Kingdom.
Permanent | Full-Time | Hybrid or Remote Options Available
Are you looking to take the lead in shaping quality and validation across a growing, international organization?
Do you bring a strong understanding of compliance and system validation in regulated environments?
Ready for your next leadership role where your expertise will drive consistency, improvement, and impact?
At Cerba Research, we are committed to finding the best talent to join our team. We have partnered with Vector Talent to manage the recruitment process for this role. If you’re interested in applying, please direct all applications and questions to Vector Talent.
Our QA team is hiring. We’re looking for a QA Computer System Validation (CSV) Manager to provide oversight and support for Cerba Research computerized systems to ensure compliance with regulatory expectations and company CSV, System Development Lifecycle (SDLC), Cybersecurity, and Data Integrity requirements.
This is a key position within a transforming QA function, as we integrate new companies and sites across the Cerba Research group. You’ll lead a small but highly experienced CSV QA team, with direct influence over validation strategy, lifecycle documentation, and system compliance across multiple GxP environments.
How You Will Add Value
As a QA CSV Manager with Cerba Research, you will contribute to:
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.
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.
About You
You’re a quality-focused professional with a strong grasp of CSV principles and a desire to lead in a regulated, fast-evolving environment. You will also have/be:
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.
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