Home Based, US

As Director, Quality Assurance you will manage a team of technology auditors and compliance managers responsible for conducting technology audits and hosting technology sponsor audits and regulatory inspections.

Accountabilities:

Quality Assurance Representative

• Member of Corporate Quality acts and is recognized as an ambassador for quality across the business and with customers.
• Consults Quality functions where required for development, implementation and management of Parexel strategic objectives.
• Contact for management and peers across the org to establish and maintain a communication framework that removes constraints and ensures timely and effective action related to matters of quality.
• Continuous learning of technical knowledge skills in emerging and innovation technologies such as Artificial Intelligence/Machine Learning, Wearable Sensors, Real World Data, Cloud Computing, and Information Security best practices.
• Representation and leadership at Quality Review Boards, Quality Forums and other meetings that govern, maintain and improve Quality.
• Attend and support internal and client meetings to collaborate with and participate in discussions related to quality.
• Agreements to ensure accuracy/completeness of technology quality content Supports requests for Information and proposal activities with respect to review and updating of information to align with quality and compliance standards.

Formulation and execution of a viable, results-oriented strategy for assigned area

• Establish, promote and sustain a vision, mission, strategy and policies for quality assurance; communicate them to team, along with internal and external clients in a spirit of shared partnership
• Oversee the coordination and hosting of cross-functional Sponsor Audits and Regulatory Inspections, as well provide management support to QA staff for Sponsor Audits and Regulatory Inspections
• Implement yearly risk-based audit plan for the area of responsibility, and continuously evaluate risk and adjust audit plan accordingly, coordinate with peers and ensure execution of the annual audit plan
• Champion and support compliance with applicable regulations, laws, Parexel procedures and policies
• Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication
• Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and data
• Effectively lead and manage crisis situations, providing direction and solutions
• Act as Escalation Point within the Organization, as well as with external clients / regulatory authorities for any major compliance concerns, providing direction and solutions. Manage the assigned internal QA team, systems and process; coordinating with peers
• Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment
• Actively implement and support the use of Audit Management application and related metrics
• Support the recruitment, supervision, training and mentoring of the QA team
• 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
• Maintain and / or develop records / documents, as required to meet the needs of the team, along with those of internal and external clients
• 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.

Audits and Inspections Host

• Hosts technology service inspections, for cause audits, assist in hosting multi service qualification and supports audits involving Technology services.
• Coach and develop TQA team in hosting sponsor audits and regulatory inspections.
• As GxP Regulatory SME, provides expertise of technology portfolios to facilitate interactions with business, technology, quality management teams and clients.

Line Management

• Provide direction mentoring and development to the team, ensuring delivery on team and individual commitments in keeping with Parexel's high performance culture.
• Ensure TIME, Training, PMD compliance by staff.
• Support and mentor staff to ensure timely and high-quality completion of TQA tasks and goals.
• Maintain close oversight of TQA spend in line with the set annual budget.

Education:

• Educated to the degree level (biological sciences, pharma or health related discipline) or relevant clinical or business equivalent