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Associate Director, Quality Assurance

Parexel International Corporation

Durham, North Carolina

The Associate Director will be accountable for the formulation and execution of a viable, results-oriented strategy for assigned area. He/She will be responsible for assessing and verifying compliance with GxP standards, consistent with applicable laws, regulations, Parexel policies and procedures, client contracts and procedures, and other standards as may be applicable to particular, situations. The Associate Director will provide leadership and direction to the team, possessing vision, technical competence, outstanding communication skills, pragmatism, a bias for action and cooperative approach to problem solving with internal and external clients. Communicate compliance issues to management. The Associate Director QA will also be responsible for financial discipline and forecasting of resources within the group.

Key accountabilities:Ensure on site QA liaison during regulatory inspections of PAREXE for assigned area facilitiesManage the assigned internal QA team, systems and process; coordinating with peersDevelop an annual audit plan, coordinating with peers and ensure its executionActively manages performance consistent with the strategy/planAnticipate problems, recognizing obstacles and seeking opportunitiesDelegate effectively, focusing on results, allowing others to learn and grow in a supportive environmentActively implement and support the use of the QA database and related metricsMotivate others through personal leadership and credibilitySupport the recruitment, supervision, training and mentoring of the QA teamChampion and support compliance with applicable regulations, laws, PAREXEL procedures and policiesPromote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communicationArticulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and dataProvide management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performedThink and analyze issues globally, not only regionallyEnsure training and development of teamEffectively lead and manage crisis situations, provide direction and solutionsMaintain relevant knowledge of appropriate GxP requirements and developments as they impact ParexelMaintain and / or develop records / documents, as required to meet the needs of the team, along with those of internal and external clientsMay 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 expertiseTravel as needed

QualificationsSkills:Demonstrated ability to successfully manage multiple teams and multiple projectsAbility to develop relationships with a culturally diverse group of key stakeholders within PAREXEL, the client’s business, and regulatory authoritiesExcellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessionsExperience with Microsoft based applications and ability to learn internal computer systemsWillingness to work in a matrix environment and to value the importance of teamworkAbility to work flexibly and adjust to changing priorities and unforeseen eventsDiplomatically address sensitive issues confidentially and professionallyExcellent knowledge of, and working experience with, relevant national / international regulationsAnalyze complex situations / issues and effectively communicate situations / issues, along with potential recommendationsWork independently and consistently in a fast-paced environmentKnowledge and Experience:Proven experience in pharmaceutical quality assurance, including international quality assurance, including substantial experience in the GCP area, with demonstrable track record of establishing effective audit functions and teams; with relevant experience managing people and projects.Education:

Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experienceMaster’s degree in a science, technology or industry related discipline, preferred

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2020-06-09

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