Manage- Quality Assurance, Good Clinical Practice-Auditor Strategy

<div><p>As a Manager, Good Clinical Practices Audit Strategy is a key position within Global Development Quality Assurance guiding and leading for management of our Good Clinical Practice Audit Strategy Programs. You will create strategic partnerships and direct risk-based audit activities, supporting and oversight of assigned molecules, clinical studies and audit programs. Applying your GCP knowledge to our strategy process we implement audit risk assessments, develop audit programs, determining audit strategy, support auditors and providing metrics reports. </p><p></p><p><b>This may be for you if you: </b><br/>•    Partner to develop risk-based audit planning for assigned molecules and studies as well as vendors and processes. <br/>•    Maintain strategic audit programs based on risk indicators from study teams and Global Development.<br/>•    Ensure audits are conducted in accordance with the approved audit programs and schedules. <br/>•    Maintain relevant core study specific information to assist auditors with audit preparation and conduct. <br/>•    Apply audit outcomes to identify quality related trends and communicate compliance risks to the organization. <br/>•    Represent on complex compliance projects and initiatives both within and across functional areas or other departments, as applicable. <br/>•    May also schedule, prepare, conduct, report and follow-up on audits in support of GCP Audit group as needed. <br/>•    Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered. <br/>•    May participate in regulatory inspections within the control and/or inspection room team. <br/>•    Draft and issue periodic reports to management as requested. <br/>•    May provides education and/or training to relevant Global Development departments. </p><p></p><p>To be considered a Bachelor’s degree with 6+ years of industry experience including 4+ years of direct GCP strategy or audit experience. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Knowledge of the FDA and EU regulations and ICH guidance documents along with regulations affecting drug development. This role may require 10 – 20% travel (both domestic and international). Strong track record of project management, collaborator management and negotiation of complex situations. <br/></p><p></p><p><b><b>Salary Range (annually)</b></b></p>$114,800.00 - $187,400.00</div>