PPD Employment – Compliance Manager

Job Description:

Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. Provides guidance to operational departments as a subject matter expert (SME) for regulations, ICH GCP guidance, and PPD SOPs. Provides support to clients and internal teams for regulatory inspections of sponsors and investigative sites. May perform directed audits as part of the Quality Investigation and Support group and provide audit reports to management.

Job Responsibilities:

• Provides GCP consultation and support to PPD project teams and external clients
• Leads improvement initiatives within department
• Mentors less experienced staff and serves as a team lead for group projects.
• Leads Suspected Scientific Misconduct investigations and directed site audits
• Support inspection readiness activities

Job Requirements:

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
• Excellent oral and written communication skills
• Strong problem solving, critical thinking, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/workload

Job Details:

Company: PPD

Vacancy Type: Full Time

Job Location: Durham, NC, US

Application Deadline: N/A

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