Key Responsibilities: The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for new or revised computerized systems and that these systems are defensible during an inspection and fit for purpose by meeting user requirements. Responsibilities Evaluate proposed new computerized systems or software to assess GxP impact and provide guidance on the risk-based validation approach. 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. Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems supporting manufacturing and distribution of products. Coach 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. Resolve problems during the validation process and advise on issues such as deficiencies, deviations, and change controls. Ensure initiation, preparation and closeout of all CSV-related deviations, discrepancies and change control documents. 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 change implementation. Perform periodic assessment to review and confirm validated status and perform periodic re‑validations. Conduct quality reviews to evaluate whether processes and deliverables fulfill quality requirements, uncover errors or deficiencies, and identify strengths and opportunities for improvement. Follow up on the resolution of identified quality exposures and, if unresolved, raise escalation to the team leader. Ensure suppliers of IT services and solutions are properly assessed for competence and reliability and that the organization applies appropriate risk‑based approaches to delivery. Skills & Experience Strong understanding of GxP regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.). Demonstrated experience managing complex validation projects and maintaining validation requirements for computerized systems supporting healthcare products. Detailed understanding of computer system validation and infrastructure qualification, including risk‑managed approaches. Experience with 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 and ability to convey compliance requirements at all levels. Capability to influence, negotiate and constructively challenge to achieve productive solutions. Strong multitasking and prioritization skills. Conscientious, highly committed, and dedicated to quality. Advanced conversational English level. Qualifications / Education Bachelor’s degree in computer science, engineering, life science or a related field plus 5 years of experience with CSV validation lifecycle management. 2+ years of experience in pharmaceutical manufacturing or medical device industry in computer systems validation, process validation, QA or compliance functions. Excellent understanding of industry regulations, standards and guidelines such as GxP, validation, 21 CFR Part 11, etc. Excellent presentation and writing skills. Equal Opportunity Employer Convatec provides equal employment opportunities for all current employees and applicants for employment. No discrimination on the basis of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectionate or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law. #J-18808-Ljbffr