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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: Experience in pharmaceutical QA or microbiology, with a strong understanding of GMP and Annex 1.
- Other info: 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.
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 pharmaceutical industry, especially those involved in sterility assurance. Attend relevant conferences or webinars to connect with potential colleagues and learn about best practices that you can bring to the role.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams or projects related to contamination control and quality assurance. Highlighting your leadership experience will be crucial, especially if you're stepping up from a senior specialist role.
✨Tip Number 4
Research StudySmarter's company culture and values. Understanding our focus on continuous improvement and collaboration will help you align your responses during interviews, showing that you're a great fit 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 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 experiences that demonstrate your capability to lead a sterility assurance strategy and your commitment to quality.
Highlight Key Achievements: When detailing your work history, focus on key achievements related to contamination control, SOP development, and successful audits. Use quantifiable results where possible to showcase your impact in previous roles.
Showcase Continuous Learning: Mention any relevant certifications, memberships in professional bodies, or ongoing education that keeps you updated on regulatory developments and industry best practices. This shows your commitment to staying current in the field.
How to prepare for a job interview at Nexia
✨Showcase Your Expertise in Sterility Assurance
Make sure to highlight your significant experience in pharmaceutical QA and sterility assurance. Be prepared to discuss specific examples of how you've implemented contamination control strategies and ensured compliance with GMP, particularly Annex 1.
✨Demonstrate Leadership Skills
Even if you haven't held a formal leadership position, be ready to share instances where you've mentored or guided colleagues. Discuss how you can drive capability and performance within a team, as this role requires strong leadership qualities.
✨Prepare for Technical Questions
Expect to be asked about your knowledge of aseptic techniques, environmental monitoring systems, and microbial risk assessments. Brush up on these topics and be ready to explain your approach to investigations, deviations, and CAPAs.
✨Emphasise Collaboration and Communication
This role involves working closely with various departments. Be prepared to discuss how you've successfully collaborated with production, QC, and engineering teams in the past, and highlight your excellent communication skills.
