Job title: Stability Program Lead
Department: Quality
Location: Hamble, Southampton, UK
Working Hours: Mon – Fri, 37.5 hours per week
A brighter future awaits you
CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision 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.
Scope:
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.
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 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.
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Travel Requirements
The position requires 5% travel between the execution sites. The position may also require travel to attend global business meetings.
Knowledge, Skills and Abilities
- 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.
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Work Environment
- Primarily office-based role with extended periods working at a computer.
- May require long hours during critical project phases or regulatory activities.
Involves coordination and handling of product samples as needed.
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Experience and Education
- 5–10 years of experience in Quality Engineering, Quality Assurance, or Quality Systems, preferably within the medical device industry.
- Demonstrated experience leading, executing, or overseeing stability studies and accelerated/real time aging protocols across the product lifecycle.
- Working knowledge of domestic and international regulatory requirements, including but not limited to ISO 13485, MDD, MDR, and MDSAP.
Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required.
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What we offer:
You’ll receive competitive compensation and a fantastic benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!
We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.
If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.
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