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PAREXEL International LLC Director, Technology Quality Assurance in United States
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Director, Technology Quality Assurance United States of America, Remote Additional Locations: Remote - United States of America Job IDR0000023169 CategoryQuality Management
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About this Role
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
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.