Senior Director, Quality Assurance

2 weeks ago

Shanghai, China Parexel Full time

When our values align, there's no limit to what we can achieve.
 

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%.

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