Summary
Date Posted: Thursday, August 01, 2019 , Base Salary: Not Disclosed

JOB DETAILS:
We have an exciting career opportunity within our Global Quality and Compliance department: This role will primarily be in support of the GCP audit program but will include opportunities to participate in audits associated with the PV audit program. .

  Job Responsibilities:
• Conducting complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
• Identifying issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.
• Performing technical document review and other GxP practice activities in support of clinical development programs.
• Providing audit reports to management.
• Serving in a lead capacity providing mentorship and guidance to junior auditors. Facilitates client audits or regulatory authority inspections.

  Job Skills:
• Expertise in GxP and appropriate regional clinical research regulations and guidelines
• Excellent training/mentoring experience of junior auditors on a variety of co-audit types
• Solid experience with a wide range of GxP audits (e.g. routine, directed, vendor, internal, database, client audits, complex process and systems audits)
• Excellent oral and written communication skills
• Well developed problem solving, risk assessment and impact analysis abilities
• Extensive experience in root cause analysis
• Strong negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/work load
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Job Qualifications:
• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, and experience.

Job Education Requirements: Not Specified
Job Experience Requirements: Not Specified

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Job application procedure
Interested and qualified? Go to PPD career website on www.ppdi.referrals.selectminds.com to apply

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