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 Responsibilities
* Lead 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.
Requirements
* Degree (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).