AddressDo 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.
You will work onsite in our Holly Springs, NC location and will report to the Regional Lead of Sterility Assurance, the Senior Manager, Sterility Assurance. You will provide leadership around Sterility for the local site and be responsible for prioritization, organization and communication of workload and issues/resolutions through appropriate forums and representation of the Site at a global level. Please note this is not a people manager position.
Responsibilities
- Encourage employees to participate in continuous improvement of safety and safety culture.
- Provide guidance to the local team of Sterility Assurance professionals at CSL Enterprise global manufacturing sites.
- Provide strategic leadership to site engineering, validation, operations, and quality functions related to Sterility Assurance, culture and continuous improvements.
- Support Regional Lead in Individual Performance Management: Develop, agree, and evaluate divisional goals.
- Partner with the global function and site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to Sterility assurance governance and drive improvements.
- Plan use of resources (staff, material, equipment, and rooms) to ensure efficient achievement of goals.
- Support employee engagement through clear direction for execution, staff development, delegation of responsibilities, and continuous improvement.
- Oversee ongoing education and development of employees in collaboration with regional lead.
- Collaborate with the Global and local SA team to provide a holistic microbial contamination control strategy and improvement plan at CSL Enterprise Manufacturing sites.
- Ensure appropriate implementation, and maintenance of Sterility Assurance standards and processes consistent with global governance, regulatory requirements, and industry standards.
- Collaborate with internal and external partners for designing best practice Sterility Assurance controls for microbial contamination control strategy and life cycle management.
- Use knowledge of facility, process, and equipment to design validation controls on an aseptic facility including aseptic media fill simulation program, container closure integrity, validation and re-validation of HVAC and HEPA system, smoke studies, etc.
- Use knowledge of facility, process, and equipment to design microbiological controls of aseptic facility including environmental monitoring program, in-process monitoring, finished product monitoring, and use of new methods and technology (Rapid microbiology methods).
- Establish and maintain GEMBA processes for critical cleanliness and aseptic behavior.
- Provide expert input to deviation investigation in sterile filtration, aseptic filling, lyophilization, sterility, media fill, and bioburden test fail.
- Support local and global capacity expansion/new projects to ensure reliable supply for patients.
- Support regulatory document submissions and internal and external (pre-approval and routine) GMP inspections as SME.
- Escalate new trends and/or changes in site performance and regulatory guidance to partners.
- Communicate with the global network to ensure harmonized corrective actions across the Enterprise network.
- Participate in the Global Sterility Assurance Oversight forum representing the site and communicating Sterility Assurance issues to senior partners.
Qualifications:
- Bachelor's degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences).
- Demonstrated technical knowledge in Sterility Assurance of aseptic cleanroom facilities, their processes and equipment, to include design, validation and monitoring, life cycle management and cGMP compliance.
- 7 years of experience in the pharmaceutical manufacturing industry with direct experience in Sterility Assurance of aseptic processing.
- Professional experience supporting teams concerning aseptic cleanrooms, process, equipment, consumables and utilities, validation, and microbiological monitoring.
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU, and other regulatory agency guidelines, including direct experience completing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context.
- Experience working with regulatory authorities including submissions and inspections and audits.
- Experience with Quality Risk Management.
- In-depth knowledge with cGMP's, FDA, TGA, EU and other relevant GxP regulations including current knowledge of industry best practice with respect to Sterility Assurance principals
- Excellent skills in critical review of documents, protocols, reports, and SOPs.
Benefits Include: flexible hours M-F, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Global travel may be part of this position.
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Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
