.**JOB DESCRIPTION**:We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.As QA Auditor III/Compliance Manager you will oversee quality by leading investigations into significant quality issues, supporting client audits and regulatory authority inspections, and providing consultancy to project teams within this highly visible team that touches many different aspects of quality.**Summarized Purpose**:**Essential Functions**:- Conduct directed site audits and pre-inspection site preparation visits (mínimal travel)- Serves as a primary contact for consulting to internal PPD staff on issues of GCP and regulatory compliance, PPD procedural document compliance; risk identification andmitigation; quality events reporting and management.- Leads investigations into incidents of suspected scientific misconduct- Participates in identification, assessment, action planning and reporting of serious breaches of GCP and protocol- Conducts inspection preparation activities and provides training to investigator site and PPD project team personnel- Manages, supports, and reports on the outcomes of regulatory inspections of investigator sites, clients, and PPD- Collaborates with investigator site staff and clients on development and/or review of responses to regulatory authority inspection findings.- Prepares and presents audit/inspection findings and/or other related information at departmental, internal operations or client meetings- Leads and/or participates in process/quality improvement initiatives- Provides mentorship and guidance to junior auditors**Job Qualification**:**Education and Experience**:- 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 5+ years') or equivalent combination of education, training, & experience.**Knowledge, Skills and Abilities**:- Thorough knowledge of GCP and appropriate regional research regulations and guidelines t- 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**Working Environment**:PPD values the health and wellbeing of our employees
