Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Global System Auditor

Your tasks and responsibilities

The primary responsibilities of this role, Global System Auditor, are to: 

 

  • Manage audit team in order to ensure timely completion of the following Global System Audit Activites:
    • Design and approval of detailed system audit plans for specific assigned processes. This includes planning of the budget and resources needed;
    • Manage the development of all relevant tools necessary for the collection of audit data in line with the approved audit plans;
    • Conduct of the audits in compliance with the approved audit plans;
    • Report audit results. These should include identification of process improvement opportunities and proposed actions to increase efficiency and compliance of the processes audited;
    • Communicate system audit results to all relevant personnel within BPH, BHC and BAH. This includes all members of Management Committees (e.g. within Research & Development, Medical Affairs and Pharmacovigilance, etc.) and other functions covered by the audit;
    • Follow-up on audits. This includes the assessment of corrective/preventive actions finally decided by responsible parties, which should lead to a better performance of the processes covered in terms of compliance and/or efficiency;
  • Lead the preparation, conduct, reporting and follow-up of document audits (e.g. software validation documentation, PV and submission documents);
  • Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current applicable standards. This often involves sponsorship of issues for global QM consensus or acting as the primary consultant for quality system Expert Working Groups;
  • Support the development and refinement of the Global Quality System by participating in SOP authorship or review teams;
  • Conduct training on the system audit process and other processes owned by Research & Development Quality for internal and external customers (e.g., new hires and consultants to Medical Development, suppliers, etc.);
  • Support of Regulatory authority inspection activities as needed with focus on Pharmacovigilace, Regulatory topiccs, including BAH Pharmacovigilance inspections . 
  • Conduct and support audit activities such as trending activities regarding to Pharmacovigilance, Regulatory and other GxP activities.

 

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’s Degree in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience, or a Master’s Degree 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 R&D 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 is required (e.g., ICH, FDA, etc.), as is familiarity with the essential documents related to those processes;
  • Familiarity 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…);
  • Must 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;
  • Must also be confident and adept in the use of computerized databases and other applications;
  • Professionalism is mandatory, as the incumbent must interact directly with all levels of Bayer staff, including Vice-Presidents and higher levels;
  • The ability to develop interdepartmental relationships is critical;
  • Must 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;
  • The incumbent must possess basic people management skills in order to effectively and independently manage the audit team assigned to the projects under his/her leadership;
  • Willingness and ability to travel up to 40%.

 

#KRT

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: NJ-Whippany