Director, QA/Regulatory CDCS APAC

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">This leadership role is highly visible within the global Covance Clinical Research organization and is central to delivering Covance’s value proposition to potential clients.  This positon is required to partner with executive Covance leaders to support the growth strategy and to drive a culture of quality, compliance, and continuous improvement in the organization.  </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">This position oversees the Asia Pacific strategy and delivery of the audit (internal, contracted and vendor) and of the customer audit/inspection programs; and, the delivery of commitments made to clients in quality agreements. This position is responsible for: </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"> </span></p><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Providing strategic direction, delivery & oversight of the Asia Pacific audit & inspection function; </span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Driving proactive compliance excellence through execution of key audit/inspection activities, identifying areas of opportunity, appropriate escalation and messaging as well as trending and communicating in governance forums</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partnering with senior clinical research leadership to ensure effective inspection preparedness programs are implemented and to assure customer satisfaction</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partnering with global Regulatory and Quality Assurance leaders across business units to drive consistent QMS implementation and roll out of related global initiatives</span></li><li style="margin: 3.0pt 0in 3.0pt .25in;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Providing regulatory compliance and quality assurance advice, guidance and support to internal clinical development study teams and functions and assuring quality agreements made to clients are fulfilled.</span></li><li style="margin: 3.0pt 0in 3.0pt .25in;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Collaborating with internal stakeholders for proactive interactions and quality management </span></li><li style="margin: 3.0pt 0in 3.0pt .25in;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Representing Covance in industry quality forums. </span></li></ul><p style="margin: 3.0pt 0in 3.0pt .25in;"><span style="font-size: 10.0pt; font-family: 'Calibri',sans-serif;"> </span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable</span></li></ul><h2>Experience:</h2><h2><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Minimum Required: </span></h2><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Typically 10+ years in a clinical trial regulatory environment with extensive experience in Good Clinical Practice (GCP roles) </span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Proven experience interpreting new/updated regulations, facilitating assessment on impact on business / QMS for adoption</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to effectively cast/communicate quality strategy to internal parties</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to network within the global QA organization to drive consistent global QMS implementation/maintain global connectivity</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to distill / communicate critical information</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Experience and ability to effectively lead QA teams/staff in multiple geographic locations</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Wide experience working in various cultural settings /ability to tailor communication approaches for effective/impactful collaboration</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">GCP consultation skillsets for multidisciplinary leaders and teams to drive strategic business process improvement initiatives</span></li></ul><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong> </strong></span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Desirable:</strong></span></p><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Experience leading / engagement in regional pharmaceutical industry GCP forums </span></li></ul>