Sterility Assurance Manager (12 Month Fixed Term Contract) in Birkenhead

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. For example, implementation of a sterile filtration step or changes in bioburden action limits.

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.