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PPD

GCP Quality Compliance Specialist - Austin, TX

Supports and executes compliance strategies and initiatives across PPD.  Hosts client audits in respective PPD office(s); ensures all audit findings are responded to and appropriately followed up; tracks client audits and findings, and maintains relevant audit documentation.  Participates in collection and review of audit responses from client audits, both of PPD and of investigator sites; works with the CAPA team to assist with investigations, root cause analyses and corrective/preventive action planning; and collaborates with Clinical Quality Assurance (CQA) and Quality Risk Management (QRM) to identify audit targets and quality risk indicators within the respective region.  Investigates cases of suspected scientific misconduct and investigator restrictions; and may be involved in procedural document harmonization in China.
 
Works independently with minimal supervision or mentoring required.  Maintains Compliance tools and materials and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) department. 
 

Education and Experience:

Bachelor's degree in a scientific or related discipline

4 years of clinical drug development experience including 2 years clinical operations or quality management experience in the pharmaceutical industry and/or CRO

Or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities

Knowledge, Skills and Abilities:

Excellent oral and written communication skillsSolid organizational and time-management skills

Extensive knowledge of the clinical trial process

Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines

Effective problem solving skillsStrong attention to detailAbility to work independently as required

Strong computer skills; ability to learn and become proficient with appropriate software

Able to multi-task and prioritize competing demands/work loadProven flexibility and adaptability

PPD is an Equal Opportunity Employer

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