Sr. Manager, Auditing and Inspections
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Reporting to the Director, Auditing and Inspections, this role is responsible for the aspects of GMP/GxP audits of vendors and internal sites and contract manufacturers, assessing compliance with regulatory and Seqirus requirements, to provide quality oversight and guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement at each of the manufacturing sites.
The role is responsible for supporting strategic and quality compliance in all areas/functions of the business to ensure optimal inspection readiness, including appropriate preparation to enable a positive execution of any and all regulatory inspections and other third party audits (such as country specific import and export requirements for each site) and organising the inspection results together with corrective and preventative actions and ensuring that responses to authorities are provided in a timely manner.
This individual is also responsible to support the harmonization, maintain and enforcing global audit strategy, processes, practices, 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) or Maidenhead (UK).
Provides support for 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.
- Manage and assist to develop a global audit program and manage in collaboration with other sites the global audit schedule.
- Ensure that all audits and inspections are performed as per plan (either internally or by a 3rd party contractor).
- Assist to co-ordinate and execute supplier audits including inspections of CMOs/ Vendors/ distributors/ laboratories and service providers
Participates 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
- Support strategic resolutions to quality issues identified during regulatory or internal inspections.
- 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 stakeholders to assist to develop and communicate innovative, 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.
- Further develop and train site personnel in principles of auditing and inspections.
- Ensure auditing and inspections teams are accredited, qualified to perform required inspections and adhere to processes and SOPs ensure inspectors are trained and accredited
- Maintain and 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 supplier management as well as industry/regulatory trends in this area
- Align with the Regulatory Intelligence and Knowledge Sharing team to ensure that new/enhanced requirements are communicated to the appropriate stakeholders, both internally and externally with vendors/partners
- Identify and/or create new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internally
- Work with site to design and implement standard requirements for external vendors/partners
Provide Auditing and Inspections team leadership
- Provide leadership and guidance to the site Auditing and Inspections team to effectively execute on strategies and programs.
- Communicate assigned objectives and provide clear direction for execution and timelines to team.
- Recruit, retain, train and develop the team to legislative requirements for assigned Seqirus site
- Work in collaboration/ partnership with the Training department to further develop, implement and sustain GxP audit expertise in GMP/ GxP requirements, computer systems and computer software.
- Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
- Bachelor's degree in science or engineering related discipline. Advanced degree a plus.
- Minimum 7+ years experience required; 10+ years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred.
- Must have expert GMP, Quality, and risk management knowledge.
- Experience authoring technical legal documents. Able to critically interpret results and generate technical conclusions consistent with Quality Risk principles.
- Experience in planning, organizing and executing effective audits/inspections
- Experience authoring audit reports, investigations, quality agreements, and risk assessments.
- Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc.
- Strong at conflict management and providing constructive feedback