Director, Quality Assurance (GCP)

The Director, Quality Assurance (QA) is accountable for the formulation and execution of a viable, resultsoriented strategy for an assigned area.

Responsibilities:

- Responsible for the development, and regular adjustment, of a risk-based strategy for assessing and verifying compliance with GCP standards, consistent with applicable laws, regulations, Parexel policies and procedures, client contracts and procedures, and other standards as may be applicable to particular situations.

- Oversight for the implementation of QA required actions to support the Company in maintaining First Time Quality, including QA actions enhancing overall Quality and leading to effective risk mitigation. Provide leadership and direction to 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 and effectively lead and manage crisis situations, providing direction and solutions.

- QA Director is also responsible for financial discipline and adequate forecasting of resources within the group.

Skills:

- Demonstrate competence in quality assurance and management, emphasizing continuous improvement

- Knowledge of models and trends in quality assurance, ‘quality’ and management

- Ability to represent a positive attitude, recognizing it as a choice which determines actions and influence

- Ability to discern where to place efforts / actions, so it adds the greatest value and maximum impact

- Demonstrated ability to successfully manage multiple teams and multiple projects

- Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel, the client’s business, and regulatory authorities

- Excellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessions

- Experience with Microsoft based applications and ability to learn internal computer systems

- Willingness to work in a matrix environment and to value the importance of teamwork

- Ability to work flexibly and adjust to changing priorities and unforeseen events

- Diplomatically address sensitive issues confidentially and professionally

- Excellent knowledge of, and working experience with, relevant national / international regulations

#LI-REMOTE