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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, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact on public health while advancing your career in biotech.
- Qualifications: 5+ years of GMP experience and a degree in a related field required.
- Other info: Dynamic role with opportunities for coaching and collaboration across teams.
The predicted salary is between 48000 - 72000 £ 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.
Under the guidance of the Sr Manager Sterility Assurance, to collaborate with the manufacturing leadership teams and to spend time in manufacturing areas and provide broad consultation/support for sterility assurance issues both in LVP as well as 3rd party manufacturing facilities that work on behalf of Liverpool. Management of complex deviation investigations (e.g. sterility failure, breach of the sterile boundary) to support appropriate decision making. A recognized subject matter expert and able to perform product impact assessments for sterility assurance events.
Work with Sr Manager Sterility Assurance and Frontline QA to support batch disposition decisions. Actively coaches and supports the development of the Sterility Assurance Specialist associate through a combination of direct coaching, partnering and supporting on stretch assignments and facilitating developmental sharing. Shares accountability for supporting site level training and EM reporting with the Sterility Assurance Specialist to facilitate time spent on stretch projects.
Builds bridges and helps teams develop collaboration by working with heads of manufacturing, engineer and MS&T to implement engineering controls to reduce the likelihood of events (e.g. utilization of closed system processing). Manages large projects or processes with limited support from manager. Maintaining own knowledge of changes in Regulatory authority requirements and expectations as well as new available technologies.
To elevate emerging trends or changes in site performance to Sr Sterility Assurance manager and key stakeholders, through 1:1 communication and appropriate site and Global forums. To ensure that operational areas are fully aware of results obtained and trends that are developing and ensuring that they have the opportunity to contribute to root cause investigations. Provide communication to global network to ensure that corrective actions are harmonized across the entirety of 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. Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations. Responds 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 to maintain and deliver a site-specific sterility assurance training program aligned with regulatory requirements and harmonized with other facilities in the Seqirus network. Provide ongoing coaching of manufacturing associates and quality assurance staff as appropriate, and Induction training covering Basic Microbiology and Aseptic operator training. Provide consultation and ownership on aseptic related changes to manufacturing systems and process.
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.
Sterility Assurance Manager (12 Month Fixed Term Contract) in Liverpool employer: CSL Plasma
Contact Detail:
CSL Plasma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Manager (12 Month Fixed Term Contract) in Liverpool
✨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 that a CV just can't.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of GMP and sterility assurance. Show us you know your stuff and can handle those tricky questions!
✨Tip Number 3
Don’t forget to showcase your leadership skills! Talk about how you've coached others or led projects in your past roles. We love seeing candidates who can inspire and guide teams.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're serious about joining our team.
We think you need these skills to ace Sterility Assurance Manager (12 Month Fixed Term Contract) in Liverpool
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 your application. Mention any relevant certifications or training you've completed, especially those related to regulatory requirements and quality risk management.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s straightforward and ensures your application goes directly to us. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at CSL Plasma
✨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 quality risk management.
✨Show Your Leadership Skills
Since this role involves coaching and supporting others, think of instances where you've led a team or mentored colleagues. Be ready to share how you’ve facilitated training programmes or managed complex investigations, as this will show your capability to take charge.
✨Understand the Company Culture
Familiarise yourself with CSL Seqirus and their commitment to inclusion and belonging. During the interview, express how your values align with theirs and how you can contribute to fostering a diverse and collaborative environment.
✨Prepare for Regulatory Questions
Expect questions related to regulatory compliance and inspections. Brush up on your knowledge of TGA and FDA requirements, and be ready to discuss how you've handled similar situations in the past, ensuring timely product release and adherence to standards.
