My client is the top pharmaceutical company, its headquarter is in German, focus on cv, gi, onco and so on therapy areas.

1. Conduct, on a regional level, GCP audits of clinical studies,suppliers, and documents (such as protocols, Patient Information Sheet/Informed Consent Document, Monitoring) to assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures. This will include interviews with, and feedback to, Principal Investigators, who may be key opinion leaders in a particular therapeutic area. 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.

2. Manage clinical study site and supplier audit activities for less complex projects on a regional basis: interact with study managers to develop and refine audit plans for less complex projects; interact with the respective Head of Study Audit Management to ensure agreement, tracking, and fulfillment of the audit plan; develop audit tools (such as audit checklists); review draft audit reports; and prepare and distribute the Study Audit Summary Reports summarizing all significant study audit findings for use by the product development teams in the development of the Clinical Study Report.

3.Participate in GCP/GxP IT System Audit teams by assisting in the development of the audit plans, developing tools for conducting such audits, conducting the audit, and reporting the results as a co-auditor, if assigned.

4. Contacts the local medical department to arrange a presentation of the data, makes the presentation and provides general advice on process improvements with instruction by Global Clinical Auditor/line manager/mentor.

5. Participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by GDQ management (e.g. working alongside a Global Clinical Auditor as an Inspection Committee member, providing basic advice on preparations for inspections, assisting in the conduct of pre-inspection audits, and/or serving other roles as defined by the Inspection Committee or GDQ committee representative) to promote the successful outcome of the
inspection.
6. Provide interpretation and guidance, with instruction by Global Clinical Auditor/line manager/mentor, 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. This often involves sponsorship of issues for GDQ consensus or acting as the primary GCP country consultant for quality system Expert Working Groups.
7. Support the development and refinement of the Global Quality System by participating in SOP/OI authorship or review teams.

Requires a BS in a biomedical science, or equivalent education, with at least 4-5 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 3-4 years of pharmaceutical industry experience. The position requires at least 4 years of experience in clinical research activities (e.g., monitor, study coordinator) or in a Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) auditing environment. At least 1-2 year must include a proven record in GCP compliance activities (such as clinical trial monitoring or study coordinator activity) or audit experience within a GLP or GMP environment. Basic knowledge and experience in the application of good clinical practice (GCP) requirements is required (e.g., 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 helpful.

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 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, up to and including Senior. Vice President level and with clinical investigators, providers of services to ** and others. The ability to develop interdepartmental relationships is critical. 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. Good project management skills, including effective planning and organizational skills, attention to detail and excellent follow through. The incumbent must be aware of the key differences in how business is practiced various countries to work effectively with various cultures.It is essential to be aware of the key cultural customs and practices that will create an effective working relationship and effectively represent Bayer as a multinational corporation.
This position involves approximately 30 - 40% travel in the region the auditor is located, and elsewhere as required.

Competitive Salary and benefit

Luxury office environment.