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- Tasks: Lead sterility assurance strategy and ensure compliance with EU GMP standards.
- Company: Join a specialist pharmaceutical manufacturer dedicated to sterile production.
- Benefits: Enjoy a supportive culture with opportunities for continuous improvement and professional growth.
- Why this job: Make a real impact in quality control and contamination prevention in a dynamic environment.
- Qualifications: Significant experience in QA, microbiology, or sterility assurance is essential.
- Other info: This is a full-time, site-based role with potential for leadership development.
The predicted salary is between 43200 - 72000 £ per year.
This is a senior-level sterility assurance role at a specialist pharmaceutical manufacturing site focused on sterile and aseptic production. The successful candidate will lead the site's sterility assurance strategy and be responsible for ensuring compliance with EU GMP Annex 1, supporting inspection readiness, and embedding a culture of proactive quality and contamination control.
You’ll serve as the site’s ME for all matters related to contamination risk and aseptic practices, supporting production, QC, engineering, and facilities.
Key Responsibilities:- Develop, implement and maintain the site's Contamination Control Strategy and sterility-related quality plans.
- Lead and mentor the sterility assurance team, driving capability, ownership, and performance.
- Oversee the development of SOPs, protocols, and sterility-related documentation.
- Act as the lead SME for cleanroom and utility monitoring, aseptic process simulations, sterilisation methods, disinfection routines, and environmental controls.
- Review and interpret microbiological data and trend analyses to ensure early risk detection and mitigation.
- Support and lead investigations, deviations, CAPAs and risk assessments related to aseptic processes.
- Collaborate closely with Production, QC and Engineering to embed a site-wide sterility mindset.
- Ensure the site maintains a Sterility Assurance Risk Register and a forward-looking Quality Improvement Plan.
- Contribute to audit readiness, regulatory inspections, and continuous improvement initiatives.
- Support the wider QA leadership team with cross-functional quality projects.
- Stay up to date with regulatory developments and evolving industry best practice.
- Significant experience in pharmaceutical QA, microbiology, or sterility assurance within a sterile/aseptic manufacturing environment.
- Proven understanding of GMP, with strong expertise in Annex 1 requirements.
- Strong knowledge of environmental and utility monitoring systems, aseptic techniques, and microbial risk assessment.
- Hands-on involvement with investigations, deviations, CAPAs and audit responses.
- Excellent communication and stakeholder management skills.
- Scientific degree and membership of a relevant professional body preferred.
- Prior leadership experience is desirable, but senior specialists ready to step up will be considered.
- Full-time, site-based position.
- The company offers a supportive culture and is focused on continuous improvement across QA and manufacturing.
Contact Detail:
Nexia Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Manager
✨Tip Number 1
Familiarise yourself with the latest EU GMP Annex 1 guidelines and any recent updates. This will not only help you understand the compliance requirements but also demonstrate your commitment to staying current in the field during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in sterility assurance. Attend relevant conferences or webinars to connect with potential colleagues and learn about best practices that can enhance your knowledge and visibility.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams or projects related to contamination control and sterility assurance. Highlighting your leadership experience and problem-solving skills will be crucial in showcasing your fit for this senior role.
✨Tip Number 4
Research StudySmarter's company culture and values, particularly around quality improvement and collaboration. Tailoring your conversations during interviews to align with our mission will show that you're a great cultural fit for the team.
We think you need these skills to ace Sterility Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmaceutical QA, microbiology, or sterility assurance. Emphasise your understanding of GMP and Annex 1 requirements, as well as any leadership roles you've held.
Craft a Strong Cover Letter: In your cover letter, express your passion for sterility assurance and how your background aligns with the company's goals. Mention specific achievements that demonstrate your capability in developing contamination control strategies and leading teams.
Showcase Relevant Skills: Clearly outline your skills related to environmental monitoring, aseptic techniques, and risk assessment. Use examples from your past roles to illustrate your hands-on experience with investigations, deviations, and CAPAs.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in a sterility assurance role.
How to prepare for a job interview at Nexia
✨Know Your GMP and Annex 1 Inside Out
Make sure you have a solid understanding of Good Manufacturing Practice (GMP) and specifically the requirements of EU GMP Annex 1. Be prepared to discuss how these regulations apply to sterility assurance and provide examples from your past experience.
✨Demonstrate Leadership Skills
As this role involves leading a team, be ready to share your leadership experiences. Talk about how you've mentored others, driven performance, and fostered a culture of quality in previous positions. Highlight any specific achievements that showcase your ability to lead effectively.
✨Prepare for Technical Questions
Expect to be asked technical questions related to contamination control strategies, aseptic techniques, and environmental monitoring systems. Brush up on your knowledge in these areas and be ready to discuss how you've implemented or improved these processes in your previous roles.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss past investigations, deviations, and CAPAs you've handled. Use the STAR method (Situation, Task, Action, Result) to structure your answers, demonstrating your analytical skills and ability to mitigate risks effectively.
