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.

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.

• 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.
• Lead/Manage the IT CSV Engineers, and IT CSV Projects Contractors.
• 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, SOP's, Change Control Documentation, and Risk Assessment reports.
• Actively collaborate with project stakeholders and the IT team to define needs and achievable solutions and/or justifications to system requirements.
• Ensure initiation/preparation and closeout of all CSV related deviations.
• Develop a Compliance Plan for Periodic Reviews.
• Determine the compliance requirements for IT Compliance Assessments and establish a plan for maturity in terms of GxP, CSV and Data Integrity.
• Plan includes gap assessments/analysis to properly identify opportunities and areas of improvement.
• Actively contribute to the development of the Access Management Program, related procedures, and templates.
• Support continuous improvement and matureness of the Risk Management process to assess the overall IT Risk.
• 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.

• 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.
• Experience with GAMP 5 and Computer Systems Validation within FDA (GxP) regulated environments.
• 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.

• Collaboratively work with IT and QA/QS Organizations to ensure alignment in validation plans and processes with focus in compliance achievement.
• Good interpersonal skills with ability to analyze situations, present alternatives and lead to establish/define solutions and related action plans.
• Must be able to effectively work in a fast-paced environment, be flexible, and possess the ability to adapt to shifting priorities.
• Demonstrated ability to participate in problem-solving discussions and lead the definition of actions plans.
• Ability to manage complex projects and timelines in a matrix team environment.

Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you’ll find them. Stretch your thinking, and you’ll find new ways to make an impact.