Senior Director, Quality Assurance

The Senior Director, Quality Assurance (QA) is accountable to promote and sustain a vision, mission, strategy and policies for quality assurance, and communicate these to QA and relevant internal customers in a spirit of shared partnership, motivating others through personal leadership and credibility. Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and data. 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 partnershipEstablish strategic goals for QA and communicate these to QA and relevant internal customers in a spirit of shared partnership, motivating others through personal leadership and credibilityUsing the relevant audit models and staff utilization information to ensure that QA is resourced to meet the present and future needs of the CorporationUsing all available and relevant information to develop a realistic budgetary plan for QA and ensure that it is appropriately implemented and costs contained within the budgeted amountsEnsure training and development of teamDelegate effectively, focusing on results, allowing others to learn and grow in a supportive environmentSupport the recruitment, supervision, training and mentoring of the QA teamProvide technical support and problem resolution for the team, as needed Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and dataProvision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performedWorks closely with Sr. Management to manage current issues and anticipate upcoming auditing needsOverseeing the development and implementation of QA global internal audit program of regular audits of Parexel projects, technologies and service providersDevelops early and late phase models in accordance with a risk-based approach to auditingEnsures consistency by the regular review and harmonization of audit processes Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication Ensure on site QA liaison during regulatory inspections of Parexel facilitiesProvide suitable assistance to internal departments and to clients in preparing for Regulatory Agency inspections of non-Parexel facilities Supports Parexel staff in the preparation of suitable written responses to Regulatory Inspections or Sponsor Audit reports.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.Travel internationally on assignments as required. Travel time could be up to approx. 60%.QualificationsSkillsPossess the vision and the ability to sell that vision of the future of QA with the QA team and the CorporationAbility to build and leverage relationships with a culturally diverse group of key stakeholders within Parexel and the client’s businessOutstanding interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessionsAbility to work flexibly and adjust to changing priorities, unforeseen events and to stay calm and focused in challenging situationsDiplomatically address sensitive issues confidentially and professionallyExcellent technical skills and knowledge of relevant national / international regulations Analyze complex situations and effectively communicate the issue along with an understanding of what needs to be done to correct and ultimately prevent the issue recurringExperience with Microsoft based applications and ability to learn internal computer system

Knowledge and Experience:15+ years’ proven experience in pharmaceutical quality assurance, including international quality assurance, including substantial experience in the GxP area, with demonstrable track record of establishing effective audit functions and teams; with relevant experience managing people and projects10+ years’ demonstrated experience in managing staff and in developing successful quality assurance organizationsExcellent oral communication skills, including public presentations and successful negotiations with Regulatory Agencies and / or sponsorsExcellent written communication skills. Ability to write articles and publish. Interest and demonstrated ability to participate actively in business development efforts.

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, preferredEEO 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.