Global System Auditor in Whippany, New Jersey | DiversityInc Careers
 
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Global System Auditor

.pre {white-space: pre-wrap;} 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 Activities:

 

  • Design and approve detailed system audit plans for specific assigned processes. This includes planning of the budget and resources needed;
  • Develop 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 Bayer Pharma (BPH), Bayer Consumer Health (BCH), and Bayer Animal Health (BAH). This includes all members of Management Committees (e.g. within Pharmacovigilance, Medical Affairs, Research and  Development etc.) and other functions, as applicable, covered by the audit;
  • Follow-up with 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, submission documents, Pharmacovigilance (PV) relevant documentation);
  • Provide interpretation and guidance for internal and external customers on PV and clinical quality related regulations/guidelines (Food and Drug Administration (FDA), International Harmonization Committee (ICH), European Union (EU), etc.) and company procedures and policies, proactively maintaining cognizance of current applicable standards. This often involves sponsorship of issues for global Quality Management (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 Standard Operating Procedures (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.);
  • Conduct and support audit activities such as trending/metrics activities regarding Pharmacovigilance, Regulatory and other “Good Practices” (GxP) activities (e.g. strategic marketing, Portfolio & Operations – P&O). This will include a significant amount of travel and visiting Bayer sites on a worldwide basis;
  • Support of Regulatory Authority inspection activities as needed with focus on Pharmacovigilance, Regulatory topics, including Animal Health Pharmacovigilance inspections.

     

.pre {white-space: pre-wrap;} 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:

 

  • Requires a B.S. Degree in a biomedical science or equivalent education, with at least seven years of pharmaceutical industry experience, OR a M.S. Degree in a biomedical science or equivalent education, with at least five years of pharmaceutical industry experience;
  • A minimum of four years of product development related activities and a two year proven record in Research & Development (R&D) auditing activities;
  • Previous experience with tasks assigned to Lead Auditors in System Audits (development of standards and tools, conduct, reporting and follow-up of system audits);
  • 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;
  • 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;
  • A high level of professionalism to interact directly with all levels of Bayer staff, including Vice-Presidents and higher levels;
  • Flexibility to travel 30-40%.

 

Preferred Qualifications:

 

  • 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;
  • Familiarity with medical terminology and routine medical tests and procedures;
  • Familiarity with computer systems supporting pharmacovigilance, regulatory affairs and/or clinical development processes;
  • Must be confident and adept in the use of computerized databases and other applications;
  • Ability to develop interdepartmental relationships;
  • People management skills in order to effectively and independently manage the audit team assigned to the projects under his/her leadership.
.pre {white-space: pre-wrap;} 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.