CSV Senior Compliance Advisor

About Convatec

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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com.

Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a CSV Senior Compliance Advisor, and you’ll do the same.

Position overview

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.

Key Responsibilities

• Oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems, ensuring systems are defendable during inspections and that delivered systems/services meet user requirements.
• Implementation Projects:
• Evaluate proposed new computerized systems or software to assess GxP impact and, where GxP impact is identified, 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 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 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.

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 assessments 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 fulfill 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 act as an information resource for delivery teams and the wider business.

Skills & Experience

• Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.).
• Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
• Detailed understanding of computer system validation and infrastructure qualification, including the application of risk-managed approaches.
• Experience in electronic software applications such as EDMS, PLM, eQMS, Complaint Management Systems, ERP, etc.
• Ability to rapidly adapt to new situations and environments.
• 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.
• Ability to handle a high concentration of work through successful multitasking and prioritizing.
• Conscientious and highly committed, with a dedication to quality.

Qualifications/Education

• 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.

Travel Requirements

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

Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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