NPI & Laboratory Supervisor

Overview

Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.

 

We are seeking an experienced and motivated leader to drive the successful transfer, scale-up, and ongoing support of innovative diagnostic products within a regulated manufacturing environment. This is a unique opportunity to bridge development and operations, leading critical activities including design transfer, process validation, equipment qualification, stability programs, product release to new markets, and continuous improvement initiatives.

Responsibilities

Lead product transfers and releases into new markets and geographies.

 

Oversee equipment qualification, validation, and lifecycle management. 

Manage design transfer activities from development through manufacturing operations.

 

Lead process validation activities and transfer of Critical-to-Quality (CTQ) attributes to manufacturing.

 

Manage stability programs, stability extensions, and trending activities for product lots.

 

Develop and monitor Laboratory Operations KPIs to drive performance and continuous improvement.

 

Review and approve technical and quality documentation.

Lead process improvement initiatives and operational excellence projects. Support customer evaluations, clinical validations, and field activities. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory requirementsLead audit readiness and support internal and external audits. 

Manage quality systems including Non-Conformance, Change Control, CAPA, and TrackWise processes.

 

Qualifications

Education:

 

Minimum BSc Hons in relevant life science subject.

 

Experience:

 

Proven experience of working in an operations environment.

Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).

 

Competencies:

 

Proven experience of working in an operations environment

Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).

 

Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.

 

Microsoft excel training or substantial experience utilizing excel is required.

 

Understanding of the requirements of quality management systems- ISO13485 & 21CFR820

 

Knowledge of Non-Conformance, Change Control and CAPA systems