Sr Audit Specialist

Home Based, US

As a Parexel Compliance Manager you must have in-depth knowledge and experience of appropriate GxP compliance and other applicable regulations and laws; Parexel procedures and appropriate Parexel processes, to conduct audits and inspections; and provide expert advice to internal and external clients. To effectively lead, matrix-manage, develop, and implement assigned projects. To exhibit a high degree of flexibility and initiative; demonstrate the ability to

follow up on multiple tasks and projects; and possess the ability to handle confidential information

diplomatically.

The Compliance Manager will have a relevant role in the management/coordination/oversight of QA

compliance GxP activities in a specific geographical and/or functional/specialist area, as assigned by QA

Senior Management.QualificationsSkills:Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client’s businessExcellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessionsExperience with Microsoft based applications and ability to learn internal computer systemsWillingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamworkAbility to work flexibly and adjust to changing priorities and unforeseen eventsDiplomatically address sensitive issues confidentially and professionallyExcellent knowledge of, and working experience with, relevant national / international regulationsExperience at conducting: GCP Late Phase Investigator Site AuditsTrial Master File AuditsSupplier AuditsSystem/ Process AuditsGood knowledge of international regulatory requirements and industry guidelines governing global GCP (ICH, EMA, FDA, MHRA, PMDA) requiredKnowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferredEducation

BS/ BA degree or equivalent experienceEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.