Compliance Manager at 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.
- 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
- BS/ BA degree or equivalent experience
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