Senior IT Quality & Compliance Lead - Regulated Clinical

Waters Corporation; Wilmslow; On-site; GBP 90,000 - 130,000; Full time

Job summary

Waters Corporation in the United Kingdom is seeking an experienced IT Quality and Compliance Principal to lead the IT quality system and ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and Waters’ QMS. You will act as system owner for Clinical and EQMS platforms and coordinate with cross‑functional teams.

The role includes validating configurations, developing validation plans, and driving audits and improvements across regulated IT environments, with partners and vendors to ensure

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 with business process owners, IT leads, and external partners.

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.

Skills

Cross-functional leadership

Collaboration & communication

Clinical platforms knowledge (Veeva,Cl

Education

Bachelor’s degree in Computer Science, Information Systems, or a related field

Job description

Waters Corporation in the United Kingdom is seeking an experienced IT Quality and Compliance Principal to lead the IT quality system and ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and Waters’ QMS. You will act as system owner for Clinical and EQMS platforms and coordinate with cross‑functional teams.

The role includes validating configurations, developing validation plans, and driving audits and improvements across regulated IT environments, with partners and vendors to ensure