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- Tasks: Lead sterility assurance efforts and ensure compliance in manufacturing operations.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive pay, health benefits, and a supportive work culture.
- Why this job: Make a real impact in public health while advancing your career.
- Qualifications: 5+ years of GMP experience and a degree in a related field.
- Other info: Dynamic role with opportunities for professional growth and development.
The predicted salary is between 36000 - 60000 £ per year.
Working at the Liverpool site as part of the Global SA team under general direction from the Snr Manager of Sterility Assurance, this candidate is to provide sterility assurance support for the Seqirus Liverpool and relevant CMO Sites. They will support (and deputise for) the Snr Manager and will focus their efforts to ensure that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOPs, the Quality manual and Good Manufacturing Practice. They will also advocate/lead necessary change management processes, participate in complex manufacturing investigations including product impact assessment and maintain their own knowledge/expertise to be recognised as a site SME and act as such during regulatory inspections. They will participate in the design and delivery of training programmes. They will be competent to author product impact assessments and working closely with the site QA team assist in batch disposition decisions.
Responsibilities
- Under the guidance of the Sr Manager Sterility Assurance, collaborate with the manufacturing leadership teams and spend time in manufacturing areas to provide broad consultation/support for sterility assurance issues both in LVP as well as 3rd party manufacturing facilities.
- Manage complex deviation investigations (e.g. sterility failure, breach of the sterile boundary) to support appropriate decision making.
- Act as a recognized subject matter expert and perform product impact assessments for sterility assurance events.
- Work with Sr Manager Sterility Assurance and Frontline QA to support batch disposition decisions.
- Actively coach and support the development of the Sterility Assurance Specialist associate through direct coaching, partnering, and facilitating developmental sharing.
- Share accountability for supporting site level training and EM reporting with the Sterility Assurance Specialist.
- Build bridges and help teams develop collaboration by working with heads of manufacturing, engineering and MS&T to implement engineering controls to reduce the likelihood of events.
- Manage large projects or processes with limited support from the manager.
- Maintain knowledge of changes in Regulatory authority requirements and expectations as well as new available technologies.
- Escalate emerging trends or changes in site performance to Sr Sterility Assurance manager and key stakeholders.
- Ensure operational areas are fully aware of results obtained and trends developing, providing opportunities to contribute to root cause investigations.
- Provide communication to the global network to ensure corrective actions are harmonized across the Seqirus network.
- Implement the microbial assurance aspects of the Quality System, maintaining the sterility assurance oversight plan as part of the site Quality plan.
- Ensure compliance with established internal specifications, standard operating procedures (SOP) and government regulations.
- Respond to questions from authorities (TGA, FDA, etc.) to ensure timely product release.
- Serve as the subject matter expert for sterility assurance regulatory submissions and regulatory inspections.
- Help maintain and deliver a site-specific sterility assurance training program aligned with regulatory requirements.
- Provide ongoing coaching of manufacturing associates and quality assurance staff as appropriate, including Induction training covering Basic Microbiology and Aseptic operator training.
- Provide consultation and ownership on aseptic related changes to manufacturing systems and processes.
Education Requirements
- Bachelors degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences). Advanced degree (Masters/Ph.D) preferred.
Experience Requirements
- 5+ years' GMP experience in pharmaceutical/biotech/regulated industry.
- Evidence of Risk Based Decision making/Quality Risk Management.
- Relevant experience of Aseptic Manufacturing/Oversight or Sterility Assurance/Quality role.
This position is also available as a 12 month secondment opportunity for internal candidates.
Sterility Assurance Manager (12 Month Fixed Term Contract) employer: CSL
Contact Detail:
CSL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Manager (12 Month Fixed Term Contract)
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at CSL Seqirus. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and recent projects. Show us how your experience aligns with their mission, especially in sterility assurance and GMP practices.
✨Tip Number 3
Don’t just talk about your skills; demonstrate them! Bring examples of past projects or challenges you've tackled in sterility assurance to the table during interviews.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're genuinely interested in being part of the CSL Seqirus team.
We think you need these skills to ace Sterility Assurance Manager (12 Month Fixed Term Contract)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Sterility Assurance Manager role. Highlight your relevant experience in GMP, aseptic manufacturing, and any leadership roles you've had. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about sterility assurance and how you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Expertise: As a potential subject matter expert, don’t shy away from showcasing your knowledge in sterility assurance and regulatory requirements. We love candidates who can demonstrate their understanding of industry standards and practices!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at CSL
✨Know Your Stuff
Make sure you brush up on your knowledge of sterility assurance and Good Manufacturing Practice (GMP). Be prepared to discuss specific examples from your past experience that demonstrate your expertise in aseptic manufacturing and how you've handled complex deviation investigations.
✨Show Your Leadership Skills
As a Sterility Assurance Manager, you'll need to lead change management processes and coach others. Think of instances where you've successfully led a team or project, and be ready to share how you can support the development of others in the role.
✨Understand the Regulatory Landscape
Familiarise yourself with the latest regulatory requirements from authorities like the TGA and FDA. Be prepared to discuss how you've navigated these regulations in previous roles and how you would ensure compliance in this position.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to sterility assurance and how they handle training and development. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.
