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- Tasks: Lead and develop stability studies for innovative pharmaceutical products.
- Company: Dynamic pharmaceutical company with a strong development pipeline.
- Benefits: Competitive salary, career growth, and hands-on leadership opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while leading a talented team.
- Qualifications: Degree in a scientific discipline and extensive GMP experience required.
- Other info: Collaborative environment with a focus on continuous improvement and regulatory excellence.
The predicted salary is between 48000 - 72000 £ per year.
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).
Stability Manager employer: Nexia
Contact Detail:
Nexia Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Stability Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience with stability management. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and regulatory frameworks. Be ready to discuss your hands-on experience in GMP environments and how you've led teams in the past. Confidence is key!
✨Tip Number 3
Showcase your leadership skills! When discussing your previous roles, highlight how you’ve developed team members and managed projects. Employers love to see candidates who can inspire and elevate their teams.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented individuals like you. Plus, it’s a great way to ensure your application gets the attention it deserves.
We think you need these skills to ace Stability Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Stability Manager role. Highlight your experience in GMP environments and any leadership roles you've held. We want to see how your background aligns with the job description!
Showcase Your Technical Skills: Don’t forget to emphasise your technical stability expertise! Mention specific stability studies you've led or contributed to, and any relevant regulatory frameworks you’re familiar with. This will help us see your fit for the role.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this position and how your skills can contribute to our client's innovative projects. Keep it engaging and relevant to the role.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Nexia
✨Know Your Stability Guidelines
Make sure you brush up on ICH stability guidelines and any relevant regulatory frameworks. Being able to discuss these in detail will show that you’re not just familiar with the theory but can apply it practically in a GMP environment.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Highlight your experience in developing team members and managing performance, as this role requires strong leadership in a hands-on capacity.
✨Be Ready for Technical Questions
Expect technical questions related to stability studies and regulatory submissions. Practise explaining your approach to designing and executing stability studies, and be prepared to discuss how you’ve handled audits and inspections.
✨Demonstrate Cross-Functional Collaboration
Think of instances where you’ve worked with QA, QC, Regulatory Affairs, or other departments. Be ready to discuss how you’ve collaborated effectively to achieve common goals, as this role involves significant cross-functional teamwork.
