Stability Program Lead

Job title: Stability Program Lead

Department: Quality

Location: Hamble, Southampton, UK

Working Hours: Mon – Fri, 37.5 hours per week

Cooper Vision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of Cooper Vision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

The Stability Program Lead establishes minimum stability requirements and maintains current procedures, systems, and tools supporting stability studies worldwide. This role coordinates closely with global manufacturing sites, project managers, and execution teams to ensure timely, compliant stability execution. Responsibilities include management of Documents of External Origin (DOEO) related to stability requirements and regulatory updates. The role also partners with R&D to define stability requirements for New Product Introductions (NPIs), aligned with ISO 10993, and provides technical guidance on product, process, or material changes that may impact product stability.

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.

• Develop and maintain the stability program in accordance with ISO 13485, ISO
  11987, 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 documentation.
• Update and maintain stability-related procedures and systems to reflect current regulatory and business needs.
• Manage and control Documents of External Origin (DOEO) to ensure compliance and traceability.
• Partner with R&D to define New Product Introduction (NPI) stability requirements in alignment with ISO 10993.
• Provide guidance on product and process changes, assessing their impact on the stability program.
• Review stability protocols and reports for completeness and compliance.
• Provide oversight for data integrity and ensure readiness for audits and regulatory submissions.
• Identify opportunities to streamline stability processes and enhance program efficiency.
• Stay current with regulatory changes and industry best practices related to stability programs.

The position requires 5% travel between the execution sites. The position may also require travel to attend global business meetings.

• Ability to influence across functions, with a demonstrated track record of driving global initiatives to successful completion.
• Strong analytical and problem-solving skills, with the ability to interpret data, identify trends, and assess quality and regulatory risk.
• Excellent written and verbal communication skills, with the ability to clearly articulate regulatory expectations, technical concepts, and quality risks to diverse stakeholders.
• Strong organizational and prioritization skills, capable of managing multiple priorities in a fast paced, global environment.
• Proficiency in Microsoft Word, Excel, Project, and other relevant quality or data management systems.
• High attention to detail.
• Ability to work effectively in a multinational and multicultural environment.
• Consistently models corporate values and demonstrates integrity, accountability, and professional conduct.

• Primarily office-based role with extended periods working at a computer.
• May require long hours during critical project phases or regulatory…