Director - Audit Management - Mylan - Morgantown

Job description
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:

Will manage, coordinate and provide support to audits of GLP as well as PV in order to accurately depict the status of compliance and foster improvements based on current GXP references and interpretations. This role will oversee the operations for the strategic, operations, and tactical actions required to accomplish the business goals and objectives of the department.
Manage Operations Audit Management relative to Good Laboratory Practice (GLP), and/or Pharmacovigilance (PV), and assure the compliance of projects, products and programs with Mylan's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).
Interact with senior and mid-level management while demonstrating a high level of professionalism and the ability to manage multiple projects simultaneously.

Maintain working knowledge of relevant SOPs and GCP, GLP, PV regulations and guidelines as well as local regulations.
Track and monitor audit responses and the implementation of corrective actions. Plan, schedule, and arrange travel to various sites based upon guidance from Management.
Interacts with Audit Management colleagues at other Mylan locations to ensure consistency in application of the functional strategy and promote standardization of auditing approach within Mylan.
Conduct audits, report results to project team personnel and management, and interact with various teams to ensure corrective actions are taken to bring observations to closure as applicable.
Collaborate with colleagues and key stakeholders to develop, implement and revise, as required, policies, procedures, and processes within sphere of influence.
Communicate audit findings with the auditees and ensure understanding of findings by Clinical Operations Leads and appropriate involved individuals.
Facilitate opening and closing audit meetings with all levels of Management.
Provide guidance and support in the development of corrective actions based on current industry standards.
Requires domestic and international travel (approximately 50% of the time).

Desired Skills and Experience
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the qualifications for this position:
Minimum of a Bachelor of Science degree (or equivalent) and five years of relevant experience is required. Minimum of a Master of Science Degree with a minimum of four years of relevant experience is preferred. However, a combination of experience and/or education will be taken into consideration.
Auditing Certification preferred (either by independent body or by corporate program)
Must possess a sound knowledge of GLP & PV, cGMP regulations and applicable global, local and regional regulations and guidelines. Knowledgebase should be sufficient enough to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited. Must be familiar with all other GXP concepts
Must be familiar with all other GXP concepts
Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners
Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application
Must be adept at independent decision-making
Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes
Requires domestic and international travel (approximately 50% of the time).

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