The Opportunity

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? CSL 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.

• Drive the implementation of Quality Initiatives, Systems, Processes, and Quality Operations for early clinical phases (Phase I to III) for cell culture and mRNA platforms.
• Develop Quality strategies for Phase appropriate Quality Assurance for clinical phases (Phase I to III) stage.
• Ensuring regulatory compliance with requirements for therapeutic products manufactured for toxicology studies and clinical trials.

• Implement R&D quality systems, policies, and procedures in line with CSL Global Quality Management System (QMS)
• Primary representative for R&D Quality in site quality management forums and discussions
• Develop and maintain Phase appropriate Quality systems
• Represent R&D Quality as a senior member of the Change Control Panel
• Provide QA disposition on R&D deviations/CAPAs and Investigations for R&D clinical trial materials and Non-Clinical Toxicological studies
• Provide QA expertise to establish programs such as raw material receipt release and routine EM monitoring for the Holly Springs site.
• Manage the R&D quality unit to provide change control, batch release, and deviation management functions for early clinical phases
• Conduct internal audits of R&D functional areas as they relate to non-Clinical trial materials and clinical materials manufacture
• Assist with 3rd Party Quality audits as required
• Drive and implement Quality Continuous Improvement Projects
• Develop and build strong business relationships with local and global quality sites where manufacturing operations are shared between sites
• Develop Quality Key Indicators with key PD stakeholders to ensure the effectiveness of quality systems
• Attend and provide Quality oversight for CPT (Core Project Teams representing Quality) for new Product Development projects as required
• Manage performance and development of QA staff
• Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development
• Develop and implement a "Quality on the Floor" culture

• Bachelor's degree in pharmacy, Chemistry, Biology, or Biochemistry; advanced degree preferred
• 10+ years' experience in quality in the biopharmaceutical industry with 1 - 3+ years' leadership plus team management experience. Experience in commercial or clinical manufacturing is advantageous, including knowledge of phase appropriate quality systems.
• Sound knowledge of GxP, FDA, and EMA regulations
• Sound knowledge of pharmacopeias such as USP, EP, and other country-specific requirements
• Experience in the application of Quality Systems
• Previous experience managing a team of direct reports