Compliance Manager at Parexel

Remote | Full-time
Parexel

Title: Compliance Manager

USA – Any Region – Home Based
Location: USA – Any Region – Home Based

Job Description: 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.

Qualifications:

Skills:

  • Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client’s business
  • Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
  • Experience with Microsoft based applications and ability to learn internal computer systems
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Ability to work flexibly and adjust to changing priorities and unforeseen events
  • Diplomatically address sensitive issues confidentially and professionally
  • Excellent knowledge of, and working experience with, relevant national / international regulations
  • Experience at conducting:
    • GCP Late Phase Investigator Site Audits
    • Trial Master File Audits
    • Supplier Audits
    • System/ Process Audits
  • Good knowledge of international regulatory requirements and industry guidelines governing global GCP (ICH, EMA, FDA, MHRA, PMDA) required
  • Knowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferred

Education

  • BS/ BA degree or equivalent experience

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