Computer Systems Validation Manager

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 10000 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 atrisk 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. Its changing the careers of our people too creating new challenges and opportunities all the time. Were a business that never stands still. Join us on our journey to #ForeverCaring as a Computer System Validation (CSV) Manager and you wont either.

As a Computer System Validation (CSV) Manager 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 all GxPRegulated 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 employ riskbased methodology lead teams on those assessments and ensure 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 riskbased 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 Convateci888 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

• Bachelors degree in Computer Science Engineering or technical field OR the equivalent combination of bachelors degree and CSV and GxP years of experience as required.

• 1215 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: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.

• Experience developing validation documentation and testing protocols (IQ/OQ/PQ/UAT) within various SDLC phases and processing documentation using an Electronic Testing System.

• Experience in VERA ALM is a plus.

• Experience in Trackwise and Documentum is a plus.

• Background/experience in inspection readiness inspections support and establishing action plans based on observations/findings after inspections.

• Experience with regulatory agencies (e.g. FDA MHRA EMA ANVISA) presenting/explaining CSV documentation and processes sharing details about IT GxP processes and establishing actions plans for any possible observation or recommendation.

• Experience using Microsoft Office software as well as application of technical writing best practices and principles. Experience writing reviewing and approving procedures and compliance documentation.

• Experience validating document management quality management regulatory publishing/information management and/or learning management systems is highly advantageous.

Abilities/Skills

• Collaboratively work with IT and QA/QS Organizations to ensure alignment in validation plans and processes with focus in compliance achievement.

• Functional technology knowledge and business processes perspective to facilitate compliance and IT Security requirements are embedded in IT CSV.

• Domain of Validation SDLC (System Development Life Cycle) methodologies system documentation including but not limited to user requirements validation protocols summary reports and SOPs.

• 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 fastpaced environment be flexible and possess the ability to adapt to shifting priorities to work independently as well as part of a team.

• Demonstrated ability to participate in problemsolving discussions and lead the definition of actions plans.

• Good in handson and endtoend CSV projects experience and application of project controls including familiarity with all project lifecycle phases from requirement gathering through delivery issues/risk management change management release management.

• Understanding of data integrity and access management compliance guidelines and risks.

• Ability to manage complex projects and timelines in a matrix team environment. Able to independently identify compliance risks and escalate when necessary. Able to lead meetings to evaluate CSV implications in projects and proposed changes.

• Ability to work with multiple clients and projects and able to manage priorities.

• Experience and proficient with Word Excel PowerPoint and MS Teams.

• Good oral and written communications skills. Able to communicate and make presentations to all levels of management and technical/ nontechnical personnel.

• Leader with strong negotiation and influencing skills ensuring gaps analysis problems solutions riskbased decisions and value maximization. Good in process and organization skills.

Our progress will give you countless opportunities to move forward too. Seek out new challenges and youll find them. Stretch your thinking and youll find new ways to make an impact. And if you embrace the opportunity to drive your own growth you could go further and achieve more than ever before.

This is a big step forward.

This is work thatll move you.

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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.

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