Stability Assurance Manager

Our client is an innovative pharmaceutical company with a strong development pipeline and a growing commercial footprint. As part of their next phase of expansion, they’re looking to appoint a Stability Manager to lead and develop their internal stability function across both new and existing products.This is a hands-on leadership role, suited to someone who combines technical stability expertise with a proven track record in GMP environments and a strong understanding of regulatory frameworks (ICH Q1 and others).Key ResponsibilitiesLead the design, planning, and execution of stability studies for clinical and commercial products.Manage a small team of scientists, supporting their technical development, training, and performance.Own and maintain the Stability Master Schedule, ensuring all projects are delivered in line with GMP and internal timelines.Develop and implement product-specific stability strategies to support MAAs, RFIs, and BLAs.Author or approve stability sections for regulatory submissions (e.g., eCTD modules).Represent the Stability function during audits and regulatory inspections.Monitor KPIs and ensure the department is continuously improving and inspection-ready.Collaborate cross-functionally with QA, QC, Regulatory Affairs, Supply Chain and Product Development teams.Keep abreast of evolving global regulatory requirements and proactively adapt internal processes as needed.RequirementsDegree (BSc or higher) in a relevant scientific discipline (Biology, Chemistry, Pharmaceutical Sciences).Minimum 6 years' experience in a GMP-regulated pharmaceutical or biotech setting.Minimum 3 years in a supervisory or leadership position.Deep understanding of ICH stability guidelines and hands-on experience running stability programs.Prior experience supporting regulatory filings and health authority inspections (MHRA, FDA, EMA or equivalent).

Created: 2025-08-01