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
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a CSV Senior Manager, and you’ll do the same.

POSITION OVERVIEW

The CSV Senior Manager will oversee all aspects of computer systems validation/qualification and act as the deputy for the Head of CSA. Responsibilities include planning and coordinating inspection/audit readiness, providing validation and compliance consulting, and ensuring compliance with regulatory requirements and data integrity for GxP-regulated computerized systems. This role involves leading IT projects to improve and simplify processes, managing team leads within the CSA organization, and maintaining validated states for all GxP computerized systems. The CSV Senior Manager will also lead IT quality processes for internal audits, inspections, and compliance programs, while collaborating with IT management and quality assurance teams. Additionally, this role includes managing IT compliance and CSV personnel, including performance management and development.

SKILLS & EXPERIENCE

• Experience in Data Integrity, Periodic Reviews, Risk Management, Change Management, and Access Monitoring/Management.
• Understanding of data integrity and access management compliance guidelines and risks.
• Experience validating document management, quality management, regulatory publishing/information management, and/or learning management systems is highly advantageous.
• Experience writing, reviewing, and approving procedures and compliance documentation.
• Experience with regulatory agencies (e.g., FDA, MHRA, EMA, ANVISA), including presenting and explaining CSV documentation and processes.
• Background/experience in inspection readiness, inspection support, and establishing action plans based on observations/findings.
• Ability to manage complex projects and timelines in a matrix team environment.
• Ability to effectively manage a staff combination of employees and consultants through leadership and promotion of teamwork.
• Ability to present and discuss regulatory compliance goals or audit/inspection results to gain commitment for action/remediation plans.
• Demonstrated ability to lead meetings, define action plans, and escalate compliance risks when necessary.
• Collaboratively work with IT and QA/QS organizations to ensure alignment in validation plans and compliance processes.
• Functional technology knowledge and business process perspective to embed compliance and IT security requirements in CSV.
• Good oral and written communication skills; able to communicate and present to all levels of management and technical/non-technical personnel.
• Strong negotiation and influencing skills to drive gap analysis, risk-based decisions, and value-driven solutions.
• Good interpersonal skills with the ability to analyze situations, present alternatives, and lead solution development.
• Must be able to work effectively in a fast-paced environment, adapt to shifting priorities, and work independently or as part of a team.
• Ability to work with multiple clients and projects while managing competing priorities.

QUALIFICATIONS/EDUCATION

• Minimum of Bachelor’s degree in Computer Science, Engineering Life Science or equivalent
• Minimum of 12- years of experience in a Computer Systems Validation leadership position, developing and implementing related processes and documentation.
• Minimum of 10 years of experience in management/leadership of technical employees/contractors.
• 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.
• Knowledge/experience in CSA (Computer Software Assurance) and related processes/documentation.
• Domain of Validation, SDLC (System Development Life Cycle) methodologies, and system documentation including user requirements, validation protocols, summary reports, and SOPs.
• Experience developing validation documentation and testing protocols (IQ/OQ/PQ/UAT) within various SDLC phases.
• Experience validating and qualifying applications across business areas such as HR, Supply Chain, Manufacturing, Labs, Regulatory, QA, and Quality Systems.
• Proficient in Microsoft Office tools (Word, Excel, PowerPoint, MS Teams).
• Experience using electronic testing systems and applying technical writing best practices.

TRAVEL REQUIREMENTS

• Up to 10% travel required (may include overnight stays)
  Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
  This is stepping up to a challenge.
  This is work that’ll move you.
  

  LI-AC2

LI-Hybrid

Business Relationship:

• Establish effective partnership with Convatec 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.
• Establish effective partnership with IT Leadership to ensure alignment through organization and the compliance mindset to develop a culture oriented and educated about compliance and quality assurance.
• Provide regular communication to IT Management about key indicators and milestones related to IT CSV, Audits/ Inspections, Inspection Readiness, and Regulatory Inspections results.
• Proactively influence the updates for IT strategies, roadmaps, and processes providing key information about CSV and GxP Compliance requirements.
• Keep external networks with technology and compliance organizations (e.g., ISACA, ASQ) to ensure updated knowledge and best practices in terms of Risk Management, Data Integrity, Audits Programs, and continuous improvements initiatives.
• Escalate any issue for prompt resolution.
• Oversight/Accountability of the CSA Team Leads ensuring responsibilities are met by leads in their respective areas.

IT CSV and Inspections/Audits Support Organization:

• Lead/Manage the IT Computer Systems Validation organization including the IT CSA managers and IT CSA analysts as well as project team members.
• Responsible for main management activities as hiring, objectives definition, communication, performance reviews, professional development, and improvements plans.
• Work closely with the IT CSV and IT Compliance Managers to ensure alignment and good communication with key Stakeholders in IT, QA/QS Organization and Business areas.
• Provide coaching and mentoring to staff to ensure their continuous professional development
• Ensure that staff are kept current on IT Training for new technologies and regulations. Coordinate budget assignment with The Office of the CIO, IT GRC for training, seminars, and memberships.
• Ensure to get feedback/ input from all team members for all projects, changes, and initiatives.

IT Computer Systems Validation and Improvement/ Matureness Projects:

• Represent IT GRC in meetings about CSV evaluation for projects and changes to ensure IT complies with CSV regulations. Recommend level of validation activities required and act as the liaison between IT with other groups in QA/QS and IT Organization together with IT CSV Manager.
• Lead and collaboratively work with QA/QS in the management of risk-based strategies in validation of regulated IT systems.
• 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.
• 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 meetings in the development of a validation remediation strategy, if needed.
• Ensure timely issue escalation to Senior Management and cross-functional support teams for his work but also for any issue related to IT CSV from another colleague.
• 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.
• Coordinate all details needed for the evaluation of the Computer Software Assurance (CSA) technique while confirming guidelines of Regulatory Agencies for that topic.
• 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.
• All audits should be properly documented and communicated with audited areas.
• All audits’ documents should be in auditable status by any regulatory agency although this process is considered an internal IT process for inspection readiness.

• Responsible for defining and documenting effective Action Plans together with agreements with process/ systems owners.Evaluate to establish a program to develop, train and mentor/coach a group of IT Assessors with background/experience and/or auditing skills.

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

• Develop a detailed plan to ensure that Convatec IT has a comprehensive plan in phases to be prepared for any Internal/Mock Audit and Regulatory Inspections.
• The scope for the Inspection Readiness Plan should include all processes and computer systems managed by IT and details should be agreed with IT Management.
• Plan includes gap assessments/ analysis to properly identify opportunities and areas of improvement.
• All actions of that plan should be well documented and communicated to IT and QA/QS organizations.
• Develop and agree with Management in a detailed RACI establishing the main responsibilities per roles.
• Develop and offer awareness and training about programs for IT Compliance Assessments, Inspections Readiness and Support.
• Properly coordinate internal assessments including scope, schedule, and assessors.
• Establish an annual plan with all details of audits/ assessments per area per quarter/year.
• Ensure proper collaborative work during Regulatory Inspections coordinating details for meetings, answers to inspectors, documentation coordination and any requests completion/submission.
• Keeps close communication with QA/QS about Inspections and IT processes/systems in the agenda.
• Represent IT Department and Leadership during Inspections with Regulatory Agencies (as FDA, MHRA, EMA, ANVISA). Provides answers to QA/QS and Inspectors.

Access Management:

• Determine the scope and main regulatory requirements/deliverables related to Access Management process for IT in compliance with GxP and keep alignment with guidelines and laws related to IT Security/ Cybersecurity, and FCF/SOX.
• 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.
• 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.