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- Tasks: Ensure sterility assurance in manufacturing and lead change management processes.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive salary, health benefits, and a supportive work environment.
- Why this job: Make a real impact in public health while advancing your career.
- Qualifications: Bachelor's degree in a related field and 5+ years of GMP experience required.
- Other info: Dynamic role with opportunities for professional growth and development.
The predicted salary is between 42000 - 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.
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 escalate 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 Warrington employer: CSL Seqirus
Contact Detail:
CSL Seqirus Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Manager (12 Month Fixed Term Contract) in Warrington
✨Tip Number 1
Network like a pro! Reach out to current employees at CSL Seqirus on LinkedIn or other platforms. Ask them about their experiences and any tips they might have for landing the Sterility Assurance Manager role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of GMP and sterility assurance practices. Be ready to discuss how you’ve handled complex investigations in the past and how you can contribute to the team.
✨Tip Number 3
Showcase your leadership skills! Think of examples where you've coached or developed others in your field. This will resonate well, especially since the role involves mentoring the Sterility Assurance Specialist.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of the CSL Seqirus family.
We think you need these skills to ace Sterility Assurance Manager (12 Month Fixed Term Contract) in Warrington
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in sterility assurance and GMP. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Expertise: As a potential subject matter expert, it’s crucial to demonstrate your knowledge in aseptic manufacturing and regulatory requirements. Use specific examples from your past roles to illustrate your expertise and decision-making skills.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly see why you’re a great fit for the team!
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team at CSL Seqirus!
How to prepare for a job interview at CSL Seqirus
✨Know Your Stuff
Make sure you brush up on your knowledge of sterility assurance and Good Manufacturing Practice (GMP). Be ready 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
Since this role involves coaching and supporting others, think of instances where you've led a team or mentored colleagues. Prepare to share how you’ve facilitated training programmes or contributed to change management processes in your previous roles.
✨Be Ready for Technical Questions
Expect questions about regulatory requirements and how you stay updated with industry changes. Have examples ready of how you've implemented new technologies or processes in your previous positions, especially those related to microbial assurance and product impact assessments.
✨Demonstrate Collaboration
This role requires working closely with various teams. Think of examples where you've successfully collaborated with manufacturing leadership or quality assurance teams. Be prepared to discuss how you build bridges and foster teamwork to achieve common goals.
