CSV Senior Compliance Advisor

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 around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us on our journey to #ForeverCaring as a CSV Senior Compliance Advisor, and you’ll drive progress that really means something.

The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified in accordance with corporate quality standards.

• The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems.
• Evaluate proposed new computerized systems or software to assess GxP impact and provide 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 assist 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.
• 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 the 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.
• 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.
• Perform periodic assessments to review and confirm validated status.
• Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality.
• Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability.
• Maintain up to date knowledge of evolving regulatory requirements and acts as an information resource for the delivery teams and wider business.

• Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.).
• Demonstrated experience in successfully managing complex validation projects.
• Detailed understanding of computer system validation and infrastructure qualification.
• Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
• Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
• Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
• Conscientious and highly committed, with a dedication to quality.

• Bachelor’s degree in computer science, engineering life science or related field.
• 5 years experience with CSV validation lifecycle management and validation documentation development.
• Minimum 2 years experience with CSV, process validation, QA or compliance functions in pharmaceutical or Medical Device industry.
• Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc.
• Excellent presentation and writing skills.

Up to 10% travel within Europe (may require overnight stays).

Hybrid – 1 day per week in the office (driven by business requirements as Convatec has a flexible approach to office working).

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best.