Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.

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).

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.

At Mylan, we are not satisfied with anything less than being the best. As one of the world's leading generics and specialty pharmaceutical companies, the key to our success starts with a relentless drive to set the highest industry standards in everything we do. It takes exceptional people working together to achieve excellence. As a team, we earn our customers’ trust and loyalty by placing a high premium on always doing the right things in the right way.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer, M/F/D/V.

Opening Up a World of Opportunities