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- Tasks: Lead and develop stability studies for innovative pharmaceutical products.
- Company: Join a cutting-edge pharmaceutical company with a strong growth trajectory.
- Benefits: Enjoy a dynamic work environment with opportunities for professional development.
- Why this job: Be part of a team that impacts global health through innovative solutions.
- Qualifications: Degree in a scientific discipline and extensive experience in GMP environments required.
- Other info: Hands-on leadership role with a focus on regulatory compliance and team development.
The predicted salary is between 48000 - 84000 £ 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.
Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.
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 with professionals in the pharmaceutical industry, especially those who have experience in stability management. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in stability studies.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks mentioned in the job description, such as ICH Q1. This will not only enhance your understanding but also demonstrate your commitment to staying updated on industry standards during interviews.
✨Tip Number 3
Prepare to discuss your leadership style and how you've successfully managed teams in the past. Think of specific examples where you supported team members' development and how that contributed to project success.
✨Tip Number 4
Research the company’s current products and pipeline. Understanding their portfolio will allow you to tailor your discussions around how your expertise can directly contribute to their stability function and overall goals.
We think you need these skills to ace Stability Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GMP environments and your understanding of regulatory frameworks. Emphasise any leadership roles you've held, particularly in stability management or related fields.
Craft a Compelling Cover Letter: In your cover letter, explain why you're the perfect fit for the Stability Manager role. Discuss your technical expertise in stability studies and your experience with regulatory submissions. Be sure to mention your leadership style and how you support team development.
Showcase Relevant Experience: When detailing your work history, focus on specific achievements related to stability studies and regulatory compliance. Use metrics where possible to demonstrate your impact, such as successful audits or improvements in stability processes.
Highlight Continuous Learning: Mention any ongoing education or training related to ICH guidelines or other relevant regulations. This shows your commitment to staying updated in the field and adapting to evolving global requirements.
How to prepare for a job interview at Nexia
✨Showcase Your Technical Expertise
Make sure to highlight your technical knowledge in stability studies and GMP environments. Be prepared to discuss specific examples from your past experience that demonstrate your understanding of ICH guidelines and how you've successfully managed stability programs.
✨Demonstrate Leadership Skills
As a Stability Manager, you'll be leading a team. Share your experiences in managing and developing teams, focusing on how you've supported their growth and performance. Discuss any training initiatives you've implemented and the impact they've had.
✨Prepare for Regulatory Discussions
Since the role involves authoring stability sections for regulatory submissions, brush up on your knowledge of the submission process. Be ready to discuss your experience with regulatory bodies like the MHRA, FDA, or EMA, and how you've navigated audits and inspections.
✨Emphasise Cross-Functional Collaboration
This position requires collaboration with various departments. Prepare examples of how you've worked cross-functionally in the past, particularly with QA, QC, and Regulatory Affairs. Highlight your ability to adapt to evolving regulatory requirements and improve internal processes.