Sterility Assurance Manager

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 an advanced manufacturing facility and 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 on the front line 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.

Working at the Holly Springs site as part of the Global Sterility Assurance team under general direction from the Sr. Manager of Sterility Assurance, this position is to provide sterility assurance support for the CSL Seqirus Holly Springs site and relevant CMO Sites.  This role will support (and represent for) the Sr. 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.  The Sterility Assurance Manager 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.  The scope of the role includes the participation in the design and delivery of training programs and authoring product impact assessments and working closely with the site QA team to assist in batch disposition decisions. This is an individual contributor position with no direct reports.

The Role

• Under the guidance of the Sr. Manager Sterility Assurance, collaborate with the manufacturing leadership teams and spend time in manufacturing and quality control areas and provide real-time broad consultation/support for sterility assurance issues both in HSP as well as 3rd party manufacturing facilities that work on behalf of Holly Springs (this may require support off-hours of a 24/7 manufacturing process.)  Manages 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 the Frontline QA and the Batch release teams to support batch disposition decisions.
• Actively coaches and supports the development of the Sterility Assurance Specialist(s)t 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 SA Specialist(s)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 Sr. Manager.  Maintaining own knowledge of changes in Regulatory authority requirements and expectations as well as new available technologies.
• Escalates 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.  Ensures 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. Provides communication to global network to ensure that corrective actions are harmonized across the Seqirus network. Assists in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk. Ensures site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management and other sterility assurance programs at followed at the manufacturing floor level.
• Implements 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. Uses Sterility Assurance Risk Management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of viral, microbial, endotoxin and particulate contamination.
• Responds to questions from authorities (FEMA, FDA, etc.) to ensure timely product release. Serves as the subject matter expert for sterility assurance regulatory submissions and regulatory inspections.
• Helps maintain and deliver a site-specific sterility assurance training program aligned with regulatory requirements and harmonized with other facilities in the Seqirus network. Provides ongoing coaching of manufacturing associates and quality assurance staff as appropriate, and Induction training covering Basic Microbiology and Aseptic operator training.
• Provides 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.

Your skills and experience

• Bachelor’s degree in a related discipline (Microbiology, Biochemistry, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences). Advanced degree (Masters/Ph.D.) preferred. 
• 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.
• cGMP background in the pharmaceutical industry – experience in SA, Aseptic Manufacturing and/or Microbiology
• Relevant experience of Aseptic Manufacturing/Oversight or Sterility Assurance/Quality role.
• Proven Communication skills both written and verbal
• Experienced in Quality Risk Management.
• Proven time management skills for planning and schedule of work and experienced in change management
• Comfort working with/communicating with all levels within a business.
• Knowledge of advanced root cause analysis techniques and CAPA implementation.
• Maintain knowledge of regulatory agency requirements and expectations and Seqirus Quality Manual
• Experience of Quality Control testing techniques and industry practices including environmental monitoring, critical utilities monitoring, endotoxin, in process bioburden, sterility testing and aseptic process simulations
• Experience with Data trending and analysis
• Ability to analyse complex data and solve problems

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.