Sr. Auditor

About CSL

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!

Job Description

Job Summary:

Reporting to the Senior Manager of Audit/Inspections and Supplier Management or Manager of Audits/Inspections (If Applicable). This role is responsible for all aspects of audit and inspection management activities.

Under minimal supervision, 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 the 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). This role will need to work closely and support members of the Supplier management stream.

Major Responsibilities:

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.
• Assist in the development of a global audit program and schedule in collaboration with other sites.
• 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
• 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.
• Support to develop in principles of auditing and inspections.
• Ensure to upkeep accreditation, qualification 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 audit management as well as industry/regulatory trends in this area
• Identify and/or create new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internally

Support the Supplier Management Team

• Provide support and expertise

Minimum Qualifications:

• Bachelor's degree in science or engineering discipline Advanced degree a plus.
• Minimum of 3 years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred.
• Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations required
• Demonstrated ability to interact with and gain the support of senior management, global partners, and cross functional teams
• In depth knowledge of the regulatory environment for the manufacture of drugs.
• Must possess thorough knowledge of global cGMP regulations and ISO standards.
• Demonstrated ability to understand data sets and drive to data-based decisions