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 a deep 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 Senior Manager of Audit/Inspections and Supplier Management or Manager of Audits/Inspections (If Applicable). You will manage all aspects of audit and inspection management activities. You will oversee the aspects of GMP/GxP audits of vendors and internal sites and contract manufacturers, assessing compliance with regulatory and Seqirus requirements, to provide quality guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement at each of the manufacturing sites.

You will support the quality compliance in all areas/functions of the business to ensure inspection readiness, including appropriate preparation to promote a positive execution of any regulatory inspections and other third-party audits (such as country specific import and export requirements for each site) and organizing the inspection results together with corrective and preventative actions and ensuring that responses to authorities are provided promptly.

You will also support the harmonization, maintain and enforcing global audit strategy, processes, and SOPs that are consistent across the manufacturing sites. A role will be located at each of the Seqirus sites, Parkville (AUS), Holly Springs (USA), or Liverpool (UK). You will need to work and support members of the Supplier management stream.

The Role

• Support the preparation and execution of supplier and internal audits to verify compliance with global GMP regulations and corporate requirements
• Support to develop quality policies, procedures and standards governing and harmonizing of the global audit and inspection program for all Seqirus sites.
• Help develop a global audit program and schedule in collaboration with other sites.
• Ensure that all audits and inspections are performed following plan (either internally or by a 3rd party contractor).
• Assist to co-ordinate and implement supplier audits including inspections of CMOs/ Vendors/ distributors/ laboratories and service providers
• Participate and Support in Regulatory inspections at Seqirus sites
• Provide support and subject matter expertise to manufacturing sites, clinical sites and CMOs in preparation for regulatory inspections
• Participate in inspections to understand root causes behind quality issues
• Communicate identified quality issues globally to avoid repeated issues
• Track inspection responses and commitments to Regulatory agencies (Health authorities) across at assigned site.
• Maintain processes, procedures, and SOPs for auditing and inspections
• Partner with teams to assist to communicate thoughtful, compliant solutions using a risk-based approach for internal and external inspections
• Support the global model for corporate audits (bi-annually) to identify weakness in cGMP systems.
• Support to develop in principles of auditing and inspections.
• Ensure to upkeep accreditation, qualification to perform required inspections and follow processes and SOPs ensure inspectors are trained and accredited
• Update processes, procedures, and SOPs based on continuous improvement for conducting both internal and external audits
• Maintain and share knowledge of Regulations and Requirements
• Stay current and up-to-date with any regulations and requirements related to audit management as well as industry/regulatory trends in this area
• Identify new requirements for Seqirus to guarantee a high level of quality; communicate new Seqirus requirements internally
• Support the Supplier Management Team

Your skills and experience

• Bachelor's degree in science or engineering discipline. Advanced degree is an advantage.
• Minimum of 3 years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries.
• Experience in sterile product manufacturing, biological processes, and laboratory operations required
• Experience interacting with and gaining the support of senior management, global partners, and teams
• In-depth knowledge of the regulatory environment for the manufacture of drugs.
• Must have knowledge of global cGMP regulations and ISO standards.
• Understanding of data sets to bring data-based decisions to conclusion

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

Our Benefits

CSL 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 at CSL Seqirus.

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