Senior IT Quality & Compliance Leader, Regulated Clinical

Waters Corporation; Milford (MA); On-site; USD 132,000 - 220,000; Full time

Job summary

Waters Corporation is seeking an experienced Sr. Principal, IT Quality and Compliance to support regulated clinical trial systems and lead the IT Quality and Compliance function.

You will ensure IT systems comply with FDA 21 CFR Part 11, EU Annex 11, and Waters' QMS, while collaborating with cross-functional teams to drive improvements and audit readiness. The role includes leading validation plans, governance development, and overseeing system ownership for Clinical and EQMS platforms, with a

Qualifications

• Bachelor's degree in Computer Science, Information Systems, or a related field.
• 8+ years of 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.

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

Regulatory IT Compliance

Cross-functional leadership

Vendor collaboration

Validation & CSV

Education

Bachelor's degree in Computer Science/Information Systems

Tools

Veeva

Clindex

Job description

Waters Corporation is seeking an experienced Sr. Principal, IT Quality and Compliance to support regulated clinical trial systems and lead the IT Quality and Compliance function.

You will ensure IT systems comply with FDA 21 CFR Part 11, EU Annex 11, and Waters' QMS, while collaborating with cross-functional teams to drive improvements and audit readiness. The role includes leading validation plans, governance development, and overseeing system ownership for Clinical and EQMS platforms, with a