OverviewWaters 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.
Key WordsClinical, Regulatory, IT, Compliance, Quality
