Director, Quality Assurance

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p><b><u><span>Key Accountabilities</span></u></b><b><span>:</span></b></p><p></p><p><b>Formulation and execution of a viable, results-oriented strategy for assigned area</b></p><ul><li>Establish, promote and sustain a vision, mission, strategic and policies for quality assurance; communicate them to team, along with internal and external clients in a spirit of shared partnership</li><li>Oversee the coordination and hosting of cross-functional <span>Sponsor Audits and Regulatory Inspections, as well provide management support to QA staff for Sponsor Audits and</span> Regulatory Inspections</li><li><span>Implement yearly risk-based audit plan for the area of responsibility, and continuously evaluate risk and adjust audit </span>plan accordingly, coordinate with peers and ensure execution of the annual audit plan</li><li>Champion and support compliance with applicable regulations, laws, Parexel procedures and policies</li><li>Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication</li><li>Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and data</li><li>Works closely with Sr. Management to manage current issues and anticipate upcoming auditing needs</li><li>Effectively lead and manage crisis situations, providing direction and solutions</li><li>Act as Escalation Point within the Organization, as well as with external clients / regulatory authorities for any major compliance concerns, providing direction and solutions. Manage the assigned internal QA team, systems and process; coordinating with peers</li><li>Actively manages performance consistent with the strategy/plan</li><li>Anticipate problems, recognizing obstacles and seeking opportunities</li><li>Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment</li><li><span>Actively implement and support the use of Audit Management application and related metrics</span></li><li>Motivate others through personal leadership and credibility</li><li>Support the recruitment, supervision, training and mentoring of the QA team</li><li>Work both independently, but in coordination and in conjunction with peers</li><li>Provision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performed</li><li>Provide technical support and problem resolution for the team, as needed</li><li><span>Think and analyze issues globally, not only regionally</span></li><li><span>Ensure training and development of team</span></li><li>Build, develop, and maintain good working relationships with internal and external customer groups</li><li><span>Develop and implement a budget for assigned area; communicating needs and changes with appropriate groups</span></li><li>Be a role model, sharing yourself, your knowledge and ideas with others</li><li>Build character in the team and company through actions and intentions</li><li><span>Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel</span></li><li>Maintain and / or develop records / documents, as required to meet the needs of the team, along with those of internal and external clients</li><li><span>May serve as a member of industry association boards, task forces and committees and / or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic, or other similar groups influential in his /her area of expertise</span></li></ul><p></p><p><b><span>Work closely with QA Senior Management</span></b></p><ul><li><span>Aligns with Senior Management to manage current issues and anticipate upcoming auditing needs. Develop and implement a budget for assigned areas; communicating needs and changes with appropriate groups</span></li></ul><p></p><p><b><span>Build and maintain relationships</span></b></p><ul><li>Build, develop, and maintain good working relationships with internal and external customer groups Work well in team environment</li></ul><p></p><p><b><span>Perform other quality related tasks or projects as assigned</span></b></p><ul><li>Perform other quality related tasks or duties as assigned by QA management</li><li>Travel internationally on assignments as required. Travel time could be up to approx. 60%.</li></ul><p></p><p><b><u><span>Skills</span></u><span>:</span></b></p><ul><li>Demonstrate competence in quality assurance and management, emphasizing continuous improvement</li><li>Knowledge of models and trends in quality assurance, ‘quality’ and management</li><li>Ability to represent a positive attitude, recognizing it as a choice which determines actions and influence</li><li>Ability to discern where to place efforts / actions, so it adds the greatest value and maximum impact</li><li>Demonstrated ability to successfully manage multiple teams and multiple projects</li><li>Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel, the client’s business, and regulatory authorities</li><li>Excellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessions</li><li>Experience with Microsoft based applications and ability to learn internal computer systems</li><li>Willingness to work in a matrix environment and to value the importance of teamwork</li><li>Ability to work flexibly and adjust to changing priorities and unforeseen events</li><li>Diplomatically address sensitive issues confidentially and professionally</li><li>Excellent knowledge of, and working experience with, relevant national / international regulations</li><li>Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations</li><li>Work independently and consistently in a fast-paced environment</li><li><span>Ability to train and coach team</span></li></ul><p></p><p><b><u><span>Knowledge and Experience</span></u></b><b><span>:</span></b></p><ul><li>Proven experience in pharmaceutical quality assurance, including international quality assurance, substantial experience in the GxP area, with demonstrable track record of establishing effective audit functions and teams; and with proven experience in managing people and projects</li></ul><p></p><p><b><u><span>Education</span></u><span>:</span></b></p><ul><li>15&#43; years’ experience in quality assurance or relevant area, including 5 years of applicable GxP auditing.</li><li>7&#43; years managing a team</li><li>Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience</li><li>Strong command of written and spoken English language, local language proficiency as required</li></ul>