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 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).