Specialist Stability

• Build, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)
• Author and maintain GMP technical documents and stability reports in compliant systems
• Provide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)
• Collate, review, verify, and archive GMP stability and product quality data
• Coordinate stability study starts and sample requests with global teams
• Participate in audits and inspections across multiple sites, ensuring readiness and compliance
• Collaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor Changes
• Mentor and train staff, sharing expertise to strengthen team capabilities

• Doctorate Degree in a Life Sciences or Engineering field
• Master's degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience
• Bachelor's degree and 12 years of Quality, Operations, Scientific, or Manufacturing experience
• Thorough understanding of GMP requirements, US FDA, and ICH regulations
• Strong scientific data management and organizational skills with exceptional attention to detail
• Proven experience in managing the product stability life cycle
• Proven technical writing skills with ability to author regulatory-quality documents
• Ability to deliver accurate results on time within GMP quality systems (Veeva, LIMS, Spotfire)
• Excellent written and verbal communication skills across all levels of the organization, with the ability to build cross-functional relationships
• Proven ability to work independently and manage time-sensitive activities across teams
• Continuous improvement mindset with experience applying lean practices
• Proficiency in MS Office (Word, Excel, PowerPoint, Teams)

• Experience managing GMP stability programs for pharmaceutical products in compliance with FDA and ICH regulations
• Experience with authoring, assembling, and reviewing annual product reviews
• Expertise in GMP applications (Veeva, Spotfire, SHINY) and proficiency in MS Office (Word, Excel, PowerPoint, Teams)
• Experience collaborating across time zones in a global, matrixed team environment
• Strong analytical and problem-solving mindset
• Strong initiative and self-motivation to drive results under pressure
• Ability to work independently and balance multiple priorities while meeting challenging deadlines
• Team-oriented approach with a focus on achieving shared goals
• Strong presentation and public speaking skills for inspections and cross-team updates

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards