Stability Program Lead

Job Summary

:

The Stability Program Lead provides global leadership and oversight of the contact lens stability program, ensuring compliance with ISO 11987, applicable regulatory requirements, and internal quality standards. As the Global Process Owner, this role defines and maintains standardized stability requirements and drives consistent, compliant execution across global manufacturing and development organizations.

Essential Functions & Accountabilities:

Develop and maintain the stability program in accordance with ISO 13485, ISO11987, MDSAP, and other applicable regulations.

Ensure stability protocols, reports, and data meet regulatory and internal requirements.

Act as the primary liaison between manufacturing sites, project managers, and execution teams in Puerto Rico and the UK.

Ensure proper sample allocation and timely initiation of stability studies.

Establish minimum requirements for stability testing and do...