Associate Director - QA (Clinical Research)

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 8pt;">Covance have an opportunoty for a Quality Assurance Associate Director to join our QA group in EMEA. This role can be office or homebased within EMEA - we are flexible regarding the location.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 8pt;">The Associate Director will have line management respoonsiblity of a team of QA Managers and Senior Managers across the region, in additioin to holding strategic and regional oversight.<span style="color: black;"><br /></span></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 8pt;">Responsibilities include:</span></p><ul><li style="margin-left: .25in;"><span style="font-size: 8pt; font-family: verdana, geneva;">Staffing and oversight of regionally based QA lead team, ensuring the quality of interactions with clients in support of Quality Agreements, issue escalation and notification, corrective and preventive actions to client-specific issues, and quality governance</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; font-family: verdana, geneva;">Talent management, colleague performance management, development and engagement of regionally based team</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; color: black; font-family: verdana, geneva;">Providing regulatory compliance and quality assurance advice, guidance and support to internal CDCS teams and functions and collaborating with other internal stakeholders (e.g; Legal) for proactive client interactions and quality management</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; color: black; font-family: verdana, geneva;">Collaborating with the QA Management team to advance standards and requirements for the Client Engagement processes, including operational oversight and continuous improvement for proactive quality management </span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; color: black; font-family: verdana, geneva;">Serve as key point of QA leadership contact in developing quality assurance strategies with Clients and CDS operations; serve as RCQA representation to operational and/or quality governance as appropriate</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; color: black; font-family: verdana, geneva;">Represent QA in client capability and proposal defense meetings as necessary</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; font-family: verdana, geneva;">Escalate key issues to management in a timely manner </span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; font-family: verdana, geneva;">Supports Hosting of (complex) external audits/inspections e.g. regulatory inspections for strategic clients where needed</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt; font-family: verdana, geneva;">Perform other duties, as assigned by management</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 8pt;"> REMOTE EMEA</span></p><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 8pt;">Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science / industry experience)</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt;">Postgraduate degree (MSC or equivalent) in science or management related discipline preferable</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt;">Experience may be substituted for education.</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 8pt;">Strong clinical research experience in a regulatory / quality environment (experience in GXP roles) </span></li><li style="margin-left: .25in;"><span style="font-size: 8pt;">Experience & regulatory expertise of industry quality systems/standards</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt;">Ability to resource and lead a multidisciplinary team to drive strategic functional process improvement initiatives</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt;">Ability to communicate and negotiate with external parties effectively</span></li><li style="margin-left: .25in;"><span style="font-size: 8pt;">Ability to distill critical information</span></li></ul>