This role is responsible for the corporate Internal Audit program.
Responsibilities specific to the process may include:
• Generate or support one consolidated and risk based global annual Quality Internal Audit Program/Process to monitor implementation and compliance with GxP principles for established or revised business processes.
• Annually develops a global risk-based auditing plan and utilizes tools and measurements needed to report effectiveness of the plan and robustness of underlying business processes.
• Organize remote, hybrid or onsite audits.
• Develop a program for inspection readiness determinations, including rehearsals for health authority inspections.
• Provide coaching before and during inspections.
• Build a network of auditors who can support a variety of assignments across External Audits, Supplier Audits, Self-Inspections, and Internal Audits within CSL and with contract auditors.
• Communicate identified deficiencies and compliance risks to leadership in the impacted business operations and quality units.
• Monitor performance metrics on the audit program, and drive process improvements to the auditing quality system.
You will collaborate across all GxP sites and teams, local and global Quality Assurance and Quality Control functions, local site or function Quality associates, Affiliates, Manufacturing, R&D and others in CSL Behring, CSL Plasma, CSL Vifor and CSL Seqirus to ensure appropriate audit preparation, execution and follow up. You will have a direct contact partner for Quality Operations including manufacturing sites; Affiliate Quality network; R&D; Global Engineering and other relevant stakeholders.
As part of a global organization, you will travel approximately 40 %, globally and locally.
We ask that you have in depth knowledge about current inspection practice from the major Health Authorities, with priority on USFDA, experience inspecting for the USFDA and broad current experience in auditing.
• Bachelor's Degree in related field
• 5+ years' direct experience with Quality Auditing or conducting inspections.
• 5+ years' experience in a pharmaceutical or biopharmaceutical company.
• 5+ years' experience working at an Inspectorate, preferably USFDA.
• Direct experience executing Quality Assurance/Quality systems activities required.
• Experience interacting with regulatory authorities including regulatory inspections.
• Deep knowledge in GXP, (GMP (pharmaceuticals, medical devices, and combination products), GDP, GVP and GCP).
• Experience working in an international organization across borders.
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!