CSV Senior Compliance Advisor

Position Overview

The CSV Senior Compliance Advisor plays a key role in ensuring that IT-managed GxP computerized systems and infrastructure are validated or qualified in line with corporate quality standards and applicable regulatory requirements. This role oversees GxP-impacting projects for new or revised computerized systems, helping to ensure solutions are inspection-ready, compliant, fit for purpose, and aligned with user requirements.

Key Responsibilities:

Implementation Projects

• Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system

• Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle.

• Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.

• Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.

• Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products in alignment with applicable company policies and regulations.

• Coach the implementation teams in the proper execution of validation documents

• Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.

• Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls. Ensure initiation/preparation and closeout of all CSV related deviations.

• Supply accurate KPIs to management on Project compliance status

System Maintenance

• Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.

• Ensure all changes are implemented and documented in a compliant manner.

• Perform periodic assessment to review and confirm validated status.

• Perform periodic re-validations.

Quality Management

• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.

• Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.

• Follow up resolution of identified quality exposures and escalation to team lead if critical situations are not resolved in due course.

• Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk-based approaches to delivery taking into account the output of the supplier assessment.

• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the delivery teams and wider business.

Skills & Experience:

• Minimum of 5 years’ experience in CSV validation lifecycle management, including the development and maintenance of validation documentation for computerized systems used to support healthcare products.

• Minimum of 2 years’ experience in the pharmaceutical manufacturing or medical device industry, in computer systems validation, process validation, QA, or compliance functions.

• Strong understanding of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, Annex 11, GAMP, and related validation guidance.

• Detailed understanding of computer system validation and infrastructure qualification, including the application of risk-based approaches.

• Experience working with electronic software applications such as EDMS, PLM, eQMS, complaint management systems, ERP systems, or similar platforms.

• Excellent communication, presentation, and writing skills, with the ability to clearly convey compliance requirements at all levels.

• Strong influencing, negotiation, and constructive challenge skills, with the ability to drive productive solutions.

• Proven ability to manage multiple CSV projects simultaneously, balancing competing priorities and maintaining quality and compliance standards in a high-pressure environment.

• Ability to adapt quickly to changing situations and manage a heavy workload with resilience, focus, and strong attention to detail.

• Conscientious and highly committed, with a strong focus on quality and compliance.

Qualifications/Education:

• Bachelor’s degree in computer science, engineering, life sciences, or a related field.

Travel Requirements 

• Up to 10% of travel required (may include overnight stays)

Working Conditions  

• Remote role, based in the UK.

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About Convatec

Pioneering trusted medical solutions to improve the lives we touch:

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.