Senior Manager, Site Sterility Assurance Lead

The Opportunity

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state-of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Reporting to the Global Head of Sterility Assurance, you will work in a global functional model under general direction and provide site level leadership relating to sterility assurance for the Seqirus Holly Springs site (including relevant 3rd party CMO's performing activities on behalf of Seqirus). You are responsible for the local sterility assurance team, prioritization, organization and communication of workload and issues/resolutions to both the HS SLT through appropriate forums and representation of the Site at a global level. You will ensure that from an aseptic perspective, the daily manufacturing operation runs following its validated status, all SOPs, the Quality manual and Good Manufacturing Practice and advocate/lead necessary change management processes, participate in complex manufacturing investigations including product impact assessment and maintain their own knowledge to be the site SME and guide appropriate direction in training programs.

• To provide local leadership of the Sterility Assurance team to provide a broad consultation on sterility assurance issues both at Holly Springs site and third-party manufacturing facilities that work on behalf of Seqirus. This includes reactive work such as the coordination and management of complex deviations (e.g. sterility failure, breach of the sterile boundary), task forces and communication to ensure compliant release.
• Provide oversight of aseptic training of operational staff
• Clean Utilities monitoring results and EM data/trending and reporting into the appropriate site governance forums
• Participation in facility audits/self-inspections at site and CMO facilities and change controls for improvements in Sterility Assurance. A recognized subject matter expert and first contact for product impact assessments for sterility assurance events. Working with site Head of Quality and head of QA to make batch disposition decisions.
• Think beyond and maintain an external and strategic focus for sterility assurance to reduce the number of events and effect when they occur. Collaborate as standard using both the wider global team locally building solid relationships with heads of manufacturing, process leads, engineers, MS&T and team members to implement engineering controls to reduce the likelihood of events (e.g. use of closed system processing).
• Manage large projects or processes from manager. This will be supported by maintaining knowledge of changes in Regulatory authority requirements and expectations and new available technologies.
• To escalate new trends or changes in site performance and also in regulatory guidance to important partners, through tiered accountability, Site Quality Council and Quality Management Review Meetings. To ensure that all of the operational areas are also aware of results obtained and trends that are developing and ensuring that they have the opportunity to contribute to root cause investigations.
• Work within global network to ensure that corrective actions are harmonized across the entirety of the Seqirus network. Participate in the Global Sterility Assurance Oversight forum representing the site and communicating to senior partners on Sterility Assurance issues.
• 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 regulatory authorities to ensure product release. Be a subject matter expert for sterility assurance regulatory submissions and regulatory inspections.
• Maintain 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, and Induction training covering Basic Microbiology and Aseptic operator training. Understand the human and behavioral aspects of aseptic manufacturing.
• Provide consultation on aseptic related changes to the manufacturing process. For example, implementation of a sterile filtration step or changes in bioburden alert or action limits. Initiate changes to SOPs when a deviation from regulation is identified or a system process is not functional based on the current instructions.

• Bachelor's degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences). Advanced degree in relevant discipline can be considered.
• 7+ years' GMP experience in pharmaceutical/biotech/or other regulated industry.
• 3+ years in Sterility Assurance role, OR 3 years + in Quality or Aseptic Manufacturing with evidence of risk-based decision making and Quality Risk Management.
• cGMP background in the Pharmaceutical industry – experience in sterility assurance, aseptic manufacturing or Microbiology an advantage
• Experienced in Quality Risk Management.
• Experienced in management of teams is an advantage
• Experienced in change management
• Able to work within a global reporting matrix
• Knowledge of continuous improvement techniques and advanced root cause analysis techniques
• Knowledge of regulatory agency requirements
• Experience of Quality Control testing techniques and industry practices

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.