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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 and quality control.
- Benefits: Enjoy a supportive culture focused on continuous improvement and professional development.
- Why this job: Make a real impact in quality assurance while collaborating with diverse teams in a dynamic environment.
- Qualifications: Significant experience in QA or microbiology, with a strong understanding of GMP and Annex 1 requirements.
- Other info: Full-time, site-based role with opportunities for leadership and growth.
The predicted salary is between 60000 - 84000 £ 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.
Sterility Assurance Manager employer: Nexia
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 sterility assurance and pharmaceutical manufacturing sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about best practices, which can give you an edge in discussions during the interview process.
✨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. Understanding our focus on continuous improvement and quality will allow you to tailor your responses in interviews, showing that you're not just a fit for the role, but also for our 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 Compelling Cover Letter: In your cover letter, express your passion for sterility assurance and how your background aligns with the company's goals. Mention specific experiences that demonstrate your capability in developing contamination control strategies and leading teams.
Showcase Your Achievements: When detailing your previous roles, focus on quantifiable achievements. For example, discuss how you improved compliance rates or led successful investigations related to aseptic processes.
Prepare for Potential Questions: Anticipate questions related to your experience with cleanroom monitoring, aseptic techniques, and risk assessments. Be ready to discuss how you've contributed to audit readiness and continuous improvement initiatives in past roles.
How to prepare for a job interview at Nexia
✨Showcase Your Expertise in Sterility Assurance
Make sure to highlight your experience in sterility assurance and your understanding of EU GMP Annex 1 requirements. Be prepared to discuss specific examples from your past roles where you successfully implemented contamination control strategies or led investigations.
✨Demonstrate Leadership Skills
Since this role involves leading a team, it's crucial to convey your leadership style and how you've mentored others in the past. Share instances where you drove performance and ownership within your team, as well as how you fostered a culture of quality.
✨Prepare for Technical Questions
Expect technical questions related to cleanroom monitoring, aseptic techniques, and microbial risk assessment. Brush up on your knowledge of environmental controls and be ready to discuss how you've applied these in real-world scenarios.
✨Emphasise Collaboration and Communication
This position requires close collaboration with various departments. Be ready to talk about how you've effectively communicated and worked with production, QC, and engineering teams in the past to embed a sterility mindset across the site.
