Global System Auditor
Your tasks and responsibilities
The Global System Auditor plays a significant role in the ability of Bayer (Pharma, Consumer Health) to operate as a business by significantly influencing how all Product Development processes meet the expectations in terms of regulatory compliance and efficiency/productivity at a global level. This is achieved through the following activities:
- Plan, prepare , conduct, reporting and follow-up of system audits on a global level and for any of the processes owned by Research and Development, Medical Affairs and Pharmacovigilance, Clinical Sciences and other interfacing departments within and outside of Pharma and Consumer Health e.g. Sales, Marketing, Product Supply), including planning of the budget and resources needed. This will include a significant amount of travel and visiting Bayer sites on a worldwide basis.
- Development of all relevant tools necessary for the collection of audit data in line with the approved audit plans.
- Communication of system audit results (incl. identification of process improvement opportunities and proposed actions) to all relevant personnel. This includes all members of Management Committees (e.g. within Research and Development, Medical Affairs and Pharmacovigilance, etc.) and other Bayer functions covered by the audit.
- Lead and drive audit activities such as trending activities regarding to Pharmacovigilance, Regulatory and other GxP activities.
- Active support of Regulatory authority inspection activities as needed with focus on Pharmacovigilance, Regulatory topics
Who you are
- BS in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 5 years of pharmaceutical industry experience
- Minimum of 4 years of product development related activities and a 2 year proven record in Research & Development auditing activities
- Oral and written proficiency in the English language
- Strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results
- Ability to assimilate large amounts of data efficiently, exercise sound judgement, and maintain composure to effectively handle sensitive issues, such as instances of serious process non-compliance
- Professionalism as the incumbent must interact directly with all levels of Bayer staff, incl. Vice-Presidents and higher, and ability to develop interdepartmental relationships
- Willingness to travel up to 40%.
- Previous experience with tasks assigned to lead auditors in system audits (e.g. development of standards and tools, conduct, reporting and follow-up of system audits)
- Knowledge and experience in the application of requirements relevant to the audited processes (e.g. FDA, ICH, EU-GVP) as well as familiarity with the essential documents related to those processes
- Familiarity with medical terminology, routine medical tests and procedures, computer systems used in the relevant areas and use of computerized databases
- Basic project and people management skills.
Functional Area: [sap_fa_20]
Entry Level: 5