Stability Program Management Specialist

As a Stability Program Management Specialist, you will lead stability strategies and programs for commercial small molecule drugs, including creating protocols, overseeing reports, and managing regulatory submissions.

• Conduct stability studies and gap analyses against global manufacturing and supply requirements
• Develop expertise in stability performance of products in the global supply chain
• Serve as the stability representative on project teams for post-approval changes and premarket stability programs
• Perform change control impact assessments and manage related documentation
• Author stability sections for CTD dossiers, annual reports, and regulatory submissions
• Lead investigations for out-of-trend/out-of-specification issues and quality deviations
• Ensure consistency in stability procedures with site and departmental standards
• Participate in initiatives to streamline management of stability programs
• Support internal and external health authority inspections
• Mentor and provide guidance to stability staff

• Expertise in ICH Stability Guidelines (Q1A, Q5C) and cGMP regulations (21 CFR) (pharmaceutical stability)
• In-depth understanding of US/EU/ROW requirements, corporate directives, and industry best practices
• Proven ability to drive technical initiatives, analyze stability data, and implement science-based solutions
• Experience in authorship, critical review of investigations, and managing external service providers for stability studies
• Excellent communication, leadership, and decision-making skills
• Fluency in English and French

Carmen Aczél is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).

Full discretion is guaranteed and we will gladly answer any additional questions.