Mylan Inc., located in Morgantown, WV currently has an opening for a Global Quality Auditor.  

This exciting position in our Global Quality department will be required to provide objective audits of internal GXP systems and external businesses for Mylan Management in order to accurately depict the status of compliance and to foster improvements based on current GXP references and interpretations.

In this role, the Global Quality Auditor will:

• Prepare and conduct internal and external audits for Mylan Inc.
• Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and  impact on systems being audited.
• Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.
• Provide interpretation of complex regulations through research of current corporate and governmental expectations.
• Facilitate opening and closing audit meetings with all levels of Management.
• Perform GXP audits based on a defined audit plan within specific time constraints.
• Prepare all associated documentation including audit plans and audit reports under strict confidentiality.
• Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards.
• Track and monitor audit responses and the implementation of corrective actions.
• Author and approve Quality Compliance procedures.
• Serve as a compliance reference regarding GXP Interpretations for all levels of Management.
• Serve as a liaison within the many GXP departments of Mylan Inc. to effectively establish compliant quality systems.
• Plan, schedule, and arrange travel to various sites based upon guidance from Management.
• Requires domestic and international travel (approximately 50% of the time).

Qualified candidates should possess a sound knowledge of national, international, and supranational cGMP regulations and expectations sufficient enough to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited.

A minimum of Bachelor’s Degree of Science, plus six years relevant experience, or MS/MBA Degree with four years experience is required.  However, a combination of experience and/or education will be taken into consideration.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth.  To learn more about Mylan and to apply online, please visit our corporate website at www.mylan.com, and click on Careers (MLI_10_001520).