IT Quality Assurance Manager
2 weeks ago
We are seeking an experienced IT Quality Manager to develop and manage the Computer Systems element of our Quality Management System (QMS). This role will focus on ensuring the verification and testing of IT infrastructure and computer systems to meet compliance with business and regulatory requirements.
Key Responsibilities:- Develop, implement, and maintain policies, procedures, and work instructions related to the Computer Systems element of the QMS, adhering to regulatory standards (e.g., GAMP, EU Annex 11, 21 CFR Part 11).
- Collaborate with the Quality function to align the Computer Systems element with the overall QMS and related obligations.
- Work closely with IT staff to ensure their activities comply with the QMS.
- Keep informed of business, legal, and regulatory environments, communicating any impacts on the Computer Systems element of the QMS.
- Provide expert guidance on the interpretation and application of relevant regulations and guidelines.
- Integrate industry best practices and standards (e.g., ITIL, PRINCE, TOGAF, ISO27001) where appropriate.
- Ensure systems are evaluated, risk-assessed, and that a risk-based verification and test strategy is managed to deliver high-quality results within agreed timelines.
- Oversee the development and execution of Test Plans and Protocols, reviewing and approving Test Results and Reports.
- Manage the resolution of issues or defects related to systems under test.
- Conduct periodic reviews to ensure systems remain in a validated state.
- Support customer audits and regulatory inspections, addressing observations as necessary.
- Ensure IT deviations, CAPAs, and Change Controls are identified and tracked to completion.
- Develop and maintain training and awareness programs for IT staff on the Computer Systems element of the QMS.
- Conduct supplier audits on key IT suppliers to ensure their QMS and processes meet regulatory obligations.
- Lead QMS improvement initiatives within the IT team and facilitate professional development within the IT Quality and IT Test & Validation teams.
- BSc in Computer Science, Information Technology, or a related subject, or equivalent work experience.
- Experience in writing standard operating procedures or work instructions.
- Proven ability to coordinate and lead test teams across different user groups.
- Strong communication, time management, and organizational skills.
- Proficiency in MS Office (Word/Excel/Project) and MS SharePoint.
- Experience in pharmaceutical manufacturing or a regulated environment.
- Experience working with third-party IT service providers.
- Familiarity with IT Service Management frameworks (e.g., ITIL V3) and tools (e.g., ServiceNow).
- Knowledge of GAMP, EU Annex 11, 21 CFR Part 11, and other relevant regulations.
- Certification in software testing (ISTQB or equivalent).
- Free Life Assurance
- Company Pension Scheme
- Healthcare Cash Plan
- 32 days annual leave
- Wedding Leave
- Company Sick Pay
- Employee well-being initiatives
- Employee Assistance Programme
- On-site free parking
- Canteen Facilities
- Employee Perks scheme
- Employee Recognition scheme
- Career development opportunities
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