QA Director, GCP-CLS

<h2>Job Overview:</h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Develop and effectively communicate CLS regulatory strategies to both internal and external stakeholders </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Lead successful CLS regulatory change management initiatives. </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Propose and create appropriate organizational metrics/dashboards demonstrating quality and compliance </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Be the solutions partner to operational leaders driving business strategies, a strong culture of quality and compliance and continuous improvement </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Communicate escalation issues to management in a timely manner implementing appropriate functional and business solutions and providing regular update </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Negotiate, influence and effectively manage constructive crucial conversations with business partners and external stakeholders </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Partner with operational leaders to ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic business process improvement initiatives </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure appropriate interpretation of applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Develop resource strategies to support the functional needs and ensure recruitment, training etc. is aligned to the strategy </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Mentor RC&QA and operational resources, to drive a quality culture </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Partner with appropriate internal stakeholders to set and manage the functional budget </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Act as the RC&QA Leadership Team's delegate </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Represent Covance in external associations/forums/organizations, as an industry SME</span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Primarily remote with some required travel globally and domestically</span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Perform other duties, as assigned by management</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience) </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 11pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience may be substituted for education </span></li></ul><h2>Experience:</h2><ul><li style="color: #000000;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">16 years in regulatory environment (experience in GXP roles)</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience & regulatory expertise of industry quality systems/standards</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to effectively communicate functional strategy with external parties</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to distill critical information</span></li></ul>