Auditor GLP

The Opportunity:

• This role will be responsible for executing the global RDQ audit program within the specified GxP discipline to the accuracy and quality of scientific data as well as compliance with relevant guidelines legal requirements GxPs and CSL Corporate standards.

• The GxP auditor will conduct assigned audits draft reports and work collaboratively with the GxP compliance area QA staff to assure categorization communication and escalations of audit outcomes.

• The program is primarily focused on external audits and support for internal audits will be required occasionally.

• As part of a broader audit team and Community of Practice this role will provide recommendations leading toward continuous improvements enhancing audit skills competence and outputs.

The Role:

• Support execution of global RDQ audit plans to assess the accuracy and quality of scientific data and/or ensure compliance with relevant guidelines legal requirements relevant GxPs and CSL Corporate requirements.

• Assist in the development of a global audit program and schedule in collaboration with RDQ and functional stakeholders.

• Perform external audits of clinical investigator sites E-Systems databases contract CROs/vendors ECs/IRBs.

• Perform self-inspections/audits of internal processes/ procedures relevant to assigned GxP including but not limited to PV process/procedure Local and Regional Safety Officers (LSO/RSOs) clinical E-Systems databases.

• Development review and issue of Audit Reports outlining the findings categorized according to level of risk/s and corrective and preventive actions (CAPA) recommendations.

• Identify non-compliance trends and systematic risks for assigned GxP.

• Analyze audit observations gaps and systematic issues to help to support continuous improvement within the assigned GxP discipline as well as affiliates 3rd party vendors and interfacing functions.

• Escalate non-compliances communicating trends to line management RDQ LT and relevant GxP functional leads.

• Support continuous improvement initiatives focusing on processes procedures and standard operating procedures (SOPs) for conducting and documenting audits and inspections outcome communications.

• Partner with stakeholders to assist in developing and communicating innovative compliant solutions using a risk-based approach for internal and external inspections with recommended solutions.

• Support development of improved principles of auditing and inspections.

• Ensure the upkeep accreditation qualification to perform required inspections and adhere to processes and SOPs to ensure inspectors are trained and accredited.

• Maintain and share knowledge of Regulations and Requirements.

• Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area.

• Identify and/or create new requirements to ensure a high level of quality and communicate internally.

Skills & Experience:

• BS degree in relevant biological science science or related discipline

• 3 years of Quality Assurance experience within a GVP GCP environment preferred (other GxP environments will be considered)

• Ability to work with limited supervision and with multinational teams and external suppliers speaking different languages.

• Strong analytical and demonstrated problem solving skills excellent interpersonal/communication/influencing/negotiation skills and excellent organizational skills with respect to planning/tracking and timelines.

• Demonstrated knowledge of QMS implementation and regulatory frameworks.

• A strong understanding of the requirements for Quality Assurance in relevant GxP discipline.

• Experience in audit/inspection management and processes.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

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