Convatec Paddington, England, United Kingdom
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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 Convatec Group.
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. 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).
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, 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.
* 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.
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.
* 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.
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.
* 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.
* Good oral and written communications skills. Able to communicate and make presentations to all levels of management and technical/ nontechnical personnel.
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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