Stability Program Lead
On-site · Hamble-le-Rice, England, United Kingdom
Job Summary
Global Stability Program Lead overseeing the worldwide stability program, ensuring compliance with ISO 13485, ISO 11987, MDSAP, and other regulatory requirements; defines stability requirements, maintains procedures and DOEO management, and partners with R&D for NPIs. The role provides technical guidance on product, process, or material changes impacting stability, serves as the primary liaison between manufacturing sites (including UK and Puerto Rico), ensures proper sample allocation and timely stability initiation, and drives standardized stability execution with audits and regulatory submissions readiness. Requires strong cross-functional leadership, data integrity focus, proficiency in quality systems, and the ability to navigate a multinational environment. Travel ~5%.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required.
- 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.
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.