Quality Systems Business Process Leader

Corin ,
Cirencester, Gloucestershire
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Job Description

Corin, an orthopaedic medical device business, are seeking a Quality Systems Business Process Leader to own the compliant implementation and maintenance of systems used under GMP realm. The Quality System Business Process Owner will work closely with Quality Assurance, IT, and users to ensure these systems are developed, implemented, and/or maintained in compliance to GAMP 5, 21 CFR Part 11, and Annex 11. You will work within the Quality Assurance team based in our global head office in Love Lane, Cirencester, Gloucestershire, which is the home to nearly 400 employees. Corin provides a progressive and dynamic work environment where you can take control of your career, be accountable and drive positive change. Corin is going through an exciting period of growth with its new investment partner Permira driving global technological / robotic advancements in the implant of hip and knee surgery which in turn delivers better patient and surgical outcomes. The key responsibilities of the Quality Systems Business Process Leader are to: * Establish and maintain procedures and tools to ensure compliant and consistent approach to computer system validations (CSV), implementation of new systems, and manage plans/execution for maintenance of validated systems * Closely work with QA and IT teams to support a standardized approach to all validation policies and procedures, templates and documentation * Participate in software project teams, defining validation requirements and when appropriate, provide compliance guidance for validation activities * Create, review, and approve User Requirements Specification, Functional Requirements, Testing requirements, protocols, and reports in compliance with GAMP 5, 21 CFR Part 11, and Annex 11. * Work with cross functional teams to plan smooth implementation (launch plan) * Provide support to IT (and other functions) to facilitate projects related to systems within GMP realm * Own and lead QS related to electronic systems within GMP realm (NCRs, CAPAs, changes, validations, SOPs, Forms, Training material, etc.) * Train and coach on electronic systems within GMP realm (NCRs, CAPAs, changes, validations, etc.) * Lead Health Authority inspections and audits with regards to the validation of computer systems (limited to but not including ERP, eQMS, eTMS, spreadsheets, databases, etc.) used within GMP realm across the organization * Support QA teams globally where required Requirements The ideal Quality Systems Business Process Leader will have / be * BS/BA in Information Technology/Computer Science, Biological or Clinical Laboratory or other related discipline * Several years post qualification experience with performing computer validations * Extensive experience with working in Quality organization with a demonstrated in-depth knowledge of Quality Systems * Experience in working with regulations as defined under 21 CFR 820, ISO 13485, 21 CFR 11, Annex 11, GAMP * The ability to interact effectively with cross functional departments * Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment * Strong documentation skills * Technical understanding of clinical laboratory operations is a plus Benefits You will receive a competitive salary and annual bonus as well as; * 25 days holiday plus bank holidays. * Excellent pension - up to 9.7% provided by Corin when you contribute 5% * Life assurance (6x basic salary). * Private medical insurance with BUPA for you and your family. * Subsidised canteen and gym membership. * Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud. * Friendly and collaborative working environment

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