YOUR TASKS AND RESPONSIBILITIES

The Global System Auditor (m/f/d) plays a significant role in the ability of Bayer Pharma (BPH) and Bayer Consumer Health (BCH) 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. The primary responsibilities of this role, Global System Auditor, are to: 

• Manage audit team to ensure timely completion of Global System Audit activities by design and approval of detailed system audit plans for country and process audits in the area of R&D, Medical Affairs, Pharmacovigilance, and Commercial
• Develop relevant audit tools for collection of audit data, conduct and reporting of audits including identification of improvement areas, communication of system audit results within Bayer Pharma and Bayer Consumer Health as well as follow-up of audits including assessment of corrective/preventive actions
• Prepare, conduct, report, and follow-up of document audits (e.g. software validation documentation, submission documents, Pharmacovigilance relevant documentation)
• Provide interpretation and guidance for internal and external customers on R&D, Medical Affairs, Pharmacovigilance, and Commercial quality related regulations/guidelines (FDA, ICH, EU, GVP etc.) and company procedures and policies, proactively maintaining cognizance of current applicable standards
• Support the development and refinement of the Global Quality System by participating in SOP authorship or review teams
• Support of regulatory authority inspection activities as needed with focus on R&D, Medical Affairs, Pharmacovigilance, and Commercial topics.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor of Science in a biomedical science, or equivalent education, with at least seven years of pharmaceutical industry experience OR Master of Science in a biomedical science, or equivalent education, with at least five years of pharmaceutical industry experience;
• At least four years of product development related activities and at least two years of proven record in auditing activities;
• Previous experience with tasks assigned to Lead Auditors in System Audits (development of standard and tools, conduct, reporting and follow-up of system audits);
• Basic project management skills;
• Knowledge and experience in the application of the requirements relevant to the clinical development processes (e.g., ICH, FDA, etc.), as is familiarity with the essential documents related to those processes;
• Be familiar with medical terminology and routine medical tests and procedures;
• Familiarity with computer systems supporting the clinical development processes is essential (data collection, data management, drug safety, etc.);
• Possess strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results;
• Oral and written proficiency in the English language;
• Be confident and adept in the use of computerized databases and other applications;
• Professionalism in order to interact directly with all levels of Bayer staff, including Vice-Presidents and higher levels;
• Ability to develop interdepartmental relationships;
• Be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues, such as instances of serious process non-compliance;
• Possess basic people management skills in order to effectively and independently manage the audit team assigned to the projects under his/her leadership;
• Willingness to travel up to 40% and to accommodate time zone differences in case of remote audits.

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