IT Quality and Compliance Principal
1 week ago
Overview
Waters is looking for an experienced IT Quality and Compliance Principal to support the integration of regulated clinical trial systems and to lead the IT Quality and Compliance function. You'll collaborate with talented teams across the organization to ensure the relevant IT systems are compliant to FDA 21 CFR Part 11, EU Annex 11, and Waters' QMS.
In addition to leading IT programs in the regulated space, you will participate in internal and external audits to demonstrate evidence of IT systems compliance with the relevant standards and help drive improvements to, and efficiency within the quality system.
Responsibilities
- Serve as system owner for Waters' Clinical and EQMS platforms.
- Lead configuration, validation, testing, and documentation aligned with Waters' CSV policies.
- Develop and execute Validation Plans (VPs), including URS, FS, DS, IQ, OQ, PQ documentation.
- Establish governance frameworks for IT Quality and Compliance including development of policies, operating procedures and work instructions.
- Engage with cross-functional teams in "art of the possible" conversations and use analytical and problem-solving skills, to support them in crafting adaptable, comprehensive solutions appropriate for each need, while presenting the pros and cons of options.
- Coordinate with vendors and integration partners to stand up systems under Waters' ownership.
- Drive platform readiness from discovery through stabilization, support training, hypercare, and transition to steady-state operations.
- Ensure adherence to FDA 21 CFR Part 11, EU Annex 11, and Waters' QMS.
Qualifications
- Bachelor's degree in Computer Science, Information Systems, or a related field.
- 8+ Years experience implementing and supporting clinical and eqms systems.
- Deep understanding of clinical platforms such as Veeva and Clindex.
- Proven ability to lead cross-functional technical teams and deliver complex integration projects.
- Excellent collaboration and communication skills for working with business process owners, IT leads, and external partners.
Company Description
Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science .
Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.
-
Head of Compliance
3 days ago
Wilmslow, Cheshire East, United Kingdom Broster Buchanan Full timePosition OverviewThe Head of Compliance is responsible for developing, implementing, and overseeing the organisation's compliance framework across all educational operations. This role ensures that the institution adheres to relevant laws, regulations, accreditation requirements, funding rules, safeguarding standards, and internal policies. The Head of...
-
Sourcing & Compliance Coordinator
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Sosandar Full time £25,000 - £40,000 per yearAbout SosandarSosandar is one of the UK's fastest-growing online fashion brands, offering trend-led collections to a loyal and ever-expanding customer base. We're bold, ambitious, and passionate about what we do - and we're looking for equally driven individuals to join our exciting journey.About The RoleWe are looking for a highly motivated and...
-
Regulatory Compliance Specialist
1 week ago
Wilmslow, Cheshire East, United Kingdom The Beauty Tech Group (CurrentBody, ZIIP, Tria) Full time £60,000 - £100,000 per yearAbout Us:We are The Beauty Tech Group. Driven by a mission to bring cutting-edge beauty technology into homes across the globe, CurrentBody evolved into The Beauty Tech Group.We were built to lead, not follow—pioneering the future of beauty tech through innovation, expertise and transparency. From revolutionary at-home devices to transformative skincare...
-
Principal Policy Adviser
20 hours ago
Wilmslow, Cheshire East, United Kingdom ICO Full timePrincipal Policy Adviser – AI Policy Fixed term until March 2027 fixed term Full time / Part time Salary: £ 57,815 - £ 65,021, with potential for further progression to £73,211 with our pay progression scheme. Location: Hybrid Contracted to our Wilmslow, London, Edinburgh, Cardiff or Belfast office, however, we offer flexible home and office-based...
-
Regulatory and Quality Admin Assistant
1 week ago
Wilmslow, Cheshire East, United Kingdom CurrentBody Full time £25,000 - £35,000 per yearAbout Us:We are The Beauty Tech Group. Driven by a mission to bring cutting-edge beauty technology into homes across the globe, CurrentBody evolved into The Beauty Tech Group.We were built to lead, not follow—pioneering the future of beauty tech through innovation, expertise and transparency. From revolutionary at-home devices to transformative skincare...
-
Regulatory and Quality Admin Assistant
1 week ago
Wilmslow, Cheshire East, United Kingdom CurrentBody Full time £25,000 - £40,000 per yearAbout Us:We are The Beauty Tech Group. Driven by a mission to bring cutting-edge beauty technology into homes across the globe, CurrentBody evolved into The Beauty Tech Group.We were built to lead, not follow—pioneering the future of beauty tech through innovation, expertise and transparency. From revolutionary at-home devices to transformative skincare...
-
Principal Research Engineer
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time £100,000 - £120,000 per yearOverviewJoin our Global Research Group to lead mechanical design efforts on next-generation mass spectrometry (MS) platforms. In this senior-level role, you will collaborate closely with Research Fellows and leading scientists to explore novel MS architecture, drive subsystem innovations, and build high-fidelity prototypes in a research-driven environment....
-
Principal Clinical System Reliability Engineer
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time £60,000 - £120,000 per yearOverviewPrincipal Clinical System Reliability Engineer - Wilmslow Clinical Systems Development is a growing team being created to develop Waters Clinical and IVD Systems, Hardware and Software.This is a phenomenal opportunity to get involved at the outset of a new organisation, with a mission to better meet the unique challenges of our Clinical customers...
-
Quality and Competency Supervisor
2 weeks ago
Wilmslow, Cheshire East, United Kingdom The Curve Group Full time £60,000 - £80,000 per yearThe RoleWe are seeking a proactive and detail-oriented individual for our banking client, to support the implementation and management of 1st Line Operational Risk within the Mortgage Distribution team. This role also involves leading the implementation and oversight of our Training & Competence Scheme and the mandatory Learning & Development programme.This...
-
Carpenter/Joiner
1 week ago
Wilmslow, Cheshire East, United Kingdom Lyme Design and Build Limited Full time £30,000 - £45,000 per yearJoin Our Team at Lyme Design & Build – Experienced Joiner WantedLyme Design & Build is a well-established building company specializing in high-quality home extensions, refurbishments, and bespoke new build homes. We are dedicated to delivering exceptional craftsmanship and take pride in the work we do for our clients.Why Join Us?Be part of a growing...