Computer Systems Validation Lead

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). To learn more about Convatec, please visit .

Our search for better is changing the lives of our customers. It's changing the careers of our people too - creating new challenges and opportunities all the time. We're a business that never stands still. Join us on our journey to as a Computer System Validation (CSV) Lead and you won't either.

As a Computer System Validation (CSV) Lead you will be responsible for all aspects of computer systems validation/qualification. This includes the planning and coordination for any Inspection/Audits readiness and support. This role provides compliance consulting on various technology throughout the build, install and maintenance phases. The Lead will have oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, CSV procedures, and Data Integrity. You will lead IT in different projects/initiatives for CSV that will address areas of improvement and simplification of actual processes as the evaluation, development, and implementation of the Computer Software Assurance (CSA). This role is also responsible for providing the necessary oversight of system-related issues, employing risk-based methodology, leading teams on those assessments and ensuring that all GxP computerized systems are maintained in a validated state throughout their lifecycle. This Manager will facilitate the Demand Management process for all requirements in projects, enhancements, and changes and will review and approve CSV strategies/plans, devise compliance maturity assessments and remediation plans.

Responsibilities

Business Relationship:

• Collaborate with Quality Assurance Quality Systems, and Clinical QA Organizations to ensure that IT CSV and GxP processes and related procedures are in alignment with Quality/Regulatory Policies and SOPs.
• Collaborate with global and local business stakeholders to ensure strategies are communicated, understood and adhered to.
• Provide regular communication to Senior Director about key indicators and milestones related to IT CSV Maturity Capability and Deviations.

IT CSV and Inspections/Audits Support Organization:

• Lead/Manage the IT CSV Engineers and IT CSV Projects Contractors.
• Keep updated organizational diagrams, job descriptions, training requirements lists, and RACIs.

IT Computer Systems Validation and Improvement/Matureness Projects:

• Lead and conduct system compliance risk assessments to determine the decisions for validations and scope.
• Ensure proper development and management of GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOPs, Change Control Documentation, and Risk Assessment reports.
• Ensure all policies, processes and applications/systems that managed by IT are in GxP compliance through embedded compliance in phases for design, development, testing, documentation, implementation, training and maintenance.
• Actively collaborate with project stakeholders and the IT team to define needs and achievable solutions and/or justifications to system requirements.
• Work with overall project manager to include validation activities in implementation timelines.
• 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.
• Lead the analysis of Data Integrity impact in IT in projects, initiatives, and changes evaluations to ensure compliance in systems, applications, and processes implementations.
• Identify CSV areas that IT needs to improve and lead organization in those projects and initiatives that will address improvement and simplification.
• Provide the necessary oversight of system-related issues, employ risk-based methodology, lead teams on those assessments and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Develop a Compliance Plan for Periodic Reviews.

IT Compliance Assessments (Systems/Process):

• Determine the compliance requirements for IT Compliance Assessments and establish a plan for maturity in terms of GxP, CSV and Data Integrity.
• Define continuous improvements initiatives for the IT Compliance Assessments for systems and processes, and all related policies, procedures, templates, and plans. That program and improvements should be reviewed with IT Management, QA/QS, and IT Security.
• Responsible for defining and documenting effective Action Plans together with agreements with process/systems owners. Follow up will be performed to ensure that CAPAs are completed and well documented.

Readiness and Support - Internal/Mock Audits and Regulatory Inspections:

• Plan includes gap assessments/analysis to properly identify opportunities and areas of improvement.
• Develop and offer awareness and training about programs for IT Compliance Assessments, Inspections Readiness and Support. Also, it is important to cover key information about Regulatory Inspections and differences in terms of GMP, GLP, and GCP.
• Properly coordinate internal assessments including scope, schedule, and assessors.

Access Management:

• Actively contribute to the development of the Access Management Program, related procedures, and templates. Documentation should include details about audit trails, and monitoring activities.
• Contribute to a detailed RACI establishing the main responsibilities and roles to ensure that the IT Access Management process complies and is effectively managed/monitored.

Data Integrity:

• Active participation supporting the IT Data Integrity plan in alignment with QA strategy and plans including the Site Data Integrity Master Plan.
• Evaluate that Convatec IT has policies and procedures for Data Integrity and lead for the uniformity and alignment of that process for IT in all Convatec Sites.
• Support all actions and remediation plans related to the Data Integrity Plan in IT to ensure all elements, actions, target dates, and resources are properly defined and then communicated.
• Ensure that projects, initiatives, and changes are evaluated in terms of Data Integrity impact to achieve compliance in systems, applications, and processes implementations.
• Ensure that Data Integrity principles and processes are part of the Audits/Inspections Program for Convatec Sites to ensure compliance with current regulations.

Risk Management (RM):

• Support continuous improvement and matureness of the Risk Management process to assess the overall IT Risk, its implications to Business Operations and the definition of mitigation plans to ensure risks are minimized and/or significantly reduced.
• Provide input/feedback to the Risk Criteria about compliance aspects related to GXP and CSV.
• Actively participate in risk assessments to ensure IT CSV area/processes are considered, root cause is properly defined, and effective mitigation actions are established.

General - IT Compliance and Documentation:

• Keep updated knowledge and training in all guidelines from Regulatory Agencies to ensure proactive alignment of IT Computer Systems, Applications, and all processes to required compliance.
• Lead and contribute documenting RACIs for the IT CSV, IT Change Management and key IT processes. RACIs will establish the main responsibilities per roles in IT, QA, and related departments, in conjunction with Service Management.
• Support IT Colleagues in documentation of incidents/issues and QA Deviations in compliance with GxP and following the QA/QS SOP related to deviations and CAPAs.

Qualifications & Education

• Bachelor's degree in Computer Science, Engineering or technical field OR the equivalent combination of bachelor's degree and CSV and GxP years of experience as required.
• 12-15 years of experience in a Computer Systems Validation leadership position/role developing and implementing related processes and documentation. Also, experience in Data Integrity, Periodic Reviews, Risk Management, Change Management, and Access Monitoring/Management.
• Experience with GAMP 5 and Computer Systems Validation within FDA (GxP) regulated environments.
• Knowledge/experience in CSA (Computer Software Assurance) and related processes/documentation.
• Knowledge and experience in GxP Guidelines; 21 CFR - Parts: 11, 210, 211, 820-QSR; Annex 11- ERES.
• Experience validating and qualifying applications for different business areas as HR, Supply Chain, Manufacturing, Labs, Regulatory, Quality Assurance and Quality Systems, among others.
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