Senior Global Clinical Auditor
Bayer HealthCare Pharmaceuticals
Montville, NJ

At Bayer HealthCare Pharmaceuticals we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the Women’s Healthcare, Oncology, Diagnostic Imaging, and Neurology markets. We are a global research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and U.S. revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.

The Sr. Global Clinical Auditor contributes to the organization’s drive for business quality and efficiency by: Managing Good Clinical Practice (GCP) audit programs for multiple high priority regional and Trans regional projects reflecting regulatory and business needs. Conducting, on a global level, independent GCP compliance audits of clinical trials / suppliers / systems / documents, identifying problem areas, and developing recommendations for process improvement. Leading or participating in the preparation for, and the conduct of regulatory inspections to promote a successful outcome. Providing GCP expertise (guidance and interpretation of regulations, guidelines, and internal policies and procedures) for conducting clinical studies. Leading or participating in system audit and process development teams to provide expert input on quality resulting in improved organization performance. Training and mentoring of less experienced auditors to promote consistency, maintain required standards and increase the flexibility of the Study Audit Management Team.

Responsibilities:
Conduct, on a global level, GCP audits of clinical studies, suppliers, and documents (such as protocols, Medical Research Reports) to assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures. Provide timely feedback by means of the audit report, assess and approve corrective/preventive actions proposed by responsible parties, and contribute quality compliance data for metrical analysis. Manage clinical study site and supplier audit activities for key compounds. The leader of a Global System Audit Team ensures timely completion of all audit related activities. Participate in periodic compliance metrics trending. Lead or participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by GLOBAL R&D QUALITY management to promote the successful outcome of the inspection. 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 GCP standards. Support the development and refinement of the Global Quality System by leading or participating in SOP/OM authorship or review teams. Conduct training on the audit process and other processes owned by GLOBAL R&D QUALITY for internal and external customers. Act as a coach/mentor in the development of less-experienced auditors.

Requires a BS in a biomedical science, or equivalent education, with at least 8 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience. The position requires a minimum of 5 years of clinical research related activities (eg, monitor, study coordinator) and a 2-3 year proven record in GCP auditing activities. An in-depth knowledge and experience in the application of good clinical practice (GCP) requirements is required (eg, ICH, FDA, etc), as is familiarity with the essential documents related to clinical studies. The incumbent should be familiar with medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is needed.

****Relevant Equivalent experience supersedes education.

The incumbent 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 is required. Incumbent 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 clinical noncompliance.

This position involves approximately 30 - 40% travel in North America, Latin America, and elsewhere as required.

As a member of the Bayer HealthCare Pharmaceuticals team, you'll find an environment that celebrates diversity and welcomes the open exchange of ideas and individual perspectives. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life balance issues. To learn more about Bayer HealthCare Pharmaceuticals or to apply online, please visit our website at www.pharmajobs.bayerhealthcare.com.