Senior Director, Quality Assurance

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world'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.

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're committed to making a difference.

Oversee and manage global / regional QA Team

• 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
• Establish 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 credibility.
• Using the relevant audit models and staff utilization information to ensure that QA is resourced to meet the present and future needs of the Corporation.
• Using 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 amounts
• Ensure training and development of team
• Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment
• Motivate others through personal leadership and credibility
• Support the recruitment, supervision, training and mentoring of the QA team
• Provide 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 data
• Work both independently, but in coordination and in conjunction with peers
• Provision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performed
• Works closely with Sr. Management to manage current issues and anticipate upcoming auditing needs

Effective and efficient compliance service

• Overseeing the development and implementation of QA global internal audit program of regular audits of Parexel projects, technologies and service providers.
• Develops early and late phase models in accordance with a risk-based approach to auditing
• Ensures 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

Sales Opportunities

• Identifies and develops sales opportunities for billable audit efforts.
• Leads the Quality Assurance bid process and presentations to prospective clients.

Regulatory Agency Inspections or Sponsor Audits of Parexel facilities

• Ensure on site QA liaison during regulatory inspections of Parexel facilities
• Build, develop, and maintain good working relationships with internal and external customer groups
• Champion and support compliance with applicable regulations, laws, Parexel procedures and policies
• Provide 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.

TrackWise eQMS

• Oversee the increased adoption of TrackWise audit module as well as the utilization of the audit information held in TrackWise/Spotfire Dashboards in the development of metrics and trending reports to better inform top management of the compliance status of the company.

Collaborations

• 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

Perform other quality related task as required for the QA group

• Perform other quality related tasks or duties as required for the QA group

• Travel internationally on assignments as required. Travel time could be up to approx. 60%.