QA Director

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Essential Job Duties:</span></p><p style="margin: 0px;">                                                                </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Definition and implementation of strategy for the Audit and Inspection Team</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partnering with key stakeholders to oversee and direct compliance activities through risk based methodologies and governance forums.</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for the definition and quality of the audit/inspection program conduct and delivery ( inclusive of all customer audits, internal audits, contracted audits mock inspection and regulatory inspection activities)</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for the appropriate preparedness, conduct and success of Regulatory Inspection outcomes, of both Covance and Sponsor Inspections.</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Messages to RCQA and functional unit leaders the results of risk awareness, trending and signal detections of identified non-compliances and partners to provide insight and direction on the development appropriate improvement plans</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for reporting on key performance and process metrics as well as continuous improvement opportunities.</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Strategically evaluating and ensuring Covance’s audit and inspection program to industry standards and regulatory agency trends and identifying areas for future growth and improvement.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Engaging and driving quality management and inspection readiness within the organization.</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Developing a high performing team and all applicable resource management responsibilities inclusive of talent development.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Creation and implementation of an inspection preparedness/readiness program</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for educating and knowledge sharing of regulatory trends and associated risk strategies within the business areas.</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure functional quality, cost and delivery of tasks according to procedural requirements</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Propose and create appropriate organizational metrics/dashboards demonstrating quality and compliance</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Develop and effectively communicate functional strategies to external stakeholders</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Be the solutions partner to operational leaders driving business strategies, a strong culture of quality and compliance and continuous improvement</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Communicate escalation issues to management in a timely manner implementing appropriate functional and business solutions and providing regular update</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Negotiate, influence and effectively manage constructive crucial conversations with business partners and external stakeholders</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partner with operational leaders to ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic business process improvement initiatives</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Lead successful functional change management initiatives.</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure appropriate interpretation of applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Develop resource strategies to support the functional needs and ensure recruitment, training etc. is aligned to the strategy</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Mentor RC&QA and operational resources, to drive a quality culture</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partner with appropriate internal stakeholders to set and manage the functional budget</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Act as the RC&QA Leadership Team's delegate</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Represent Covance in external associations/forums/organizations, as an industry SME</span><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Perform other duties, as assigned by management</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience may be substituted for education</span></p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">16 years in regulatory environment (experience in GXP roles) </span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience & regulatory expertise of industry quality systems/standards</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to effectively communicate functional strategy with external parties</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to distill critical information</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to effectively lead teams through the management of people leaders at multiple sites or geographic locations</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to provide consultation, guidance and influence to leaders of multidisciplinary teams to drive strategic business process improvement initiatives</span></p>