Director, Clinical Functional Partnering

AstraZeneca • Durham, NC

2d • Hybrid

About The Position

This role is responsible for partnering across BioPharmaceuticals R&D, providing data-driven insights to inspection readiness, regulatory compliance, and empowering study teams to deliver clinical studies. The Director, Clinical Quality is responsible for the delivery of Quality Management activities related to clinical operations within R&D working with stakeholders across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities. They are also accountable for identifying and sharing industry trends in quality for the new business area(s), in their scope, through benchmarking with industry peers. Typical Accountabilities: Collaborate effectively with colleagues and stakeholders to support quality and compliance related initiatives/activities and act as a quality champion promoting a culture of quality across R&D. Provide expert advice and best practice guidance on GCP or other relevant regulatory standards (such as GCP for labs, GAMP, 21 CFR Part 11, etc.) for quality events, initiatives, and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes). Support teams as they prepare for regulatory inspections (where necessary) and internal audits. This can include activities such as interpreting readiness checklists, identifying risks and developing mitigation strategies, building quality issue storyboards, providing study team assistance & support during inspection and post inspection/audit tasks (responses, CAPA, lessons learned) Coordinate and support identification and management of quality risks, including mitigation of risks and communication of significant risks to management Support relevant Leadership Team in the strategic direction and priorities of the group and to develop clinical quality related objectives and strategies that drive a culture of quality, including communications and critical issues Develop and implement continuous improvements by collating including reporting quality related trends and metrics periodically, escalating where necessary, and tracking related activities. Maintain current knowledge and awareness of regulations / guidance as well as any internal processes pertaining to clinical trials; provide interpretations of regulations and assessing impact on our systems and providing recommendations, where necessary. Provide quality and compliance support to assigned functional areas within Clinical Operations and R&D pertaining to the above. Assist in creation and maintenance of tools and processes to proactively address readiness for internal and regulatory GCP/GXP audits and inspections and development/maintenance of other tools and processes to support and enhance the above responsibilities.

Requirements

• University degree in related discipline, preferably in life science or equivalent.
• In depth proven experience in a clinical compliance or quality related position with a track record of success in managing quality and compliance activities
• Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements.
• Demonstrated project management skills

Nice To Haves

• Higher degree in a scientific or business discipline is desirable

Responsibilities

• Collaborate effectively with colleagues and stakeholders to support quality and compliance related initiatives/activities and act as a quality champion promoting a culture of quality across R&D.
• Provide expert advice and best practice guidance on GCP or other relevant regulatory standards (such as GCP for labs, GAMP, 21 CFR Part 11, etc.) for quality events, initiatives, and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes).
• Support teams as they prepare for regulatory inspections (where necessary) and internal audits. This can include activities such as interpreting readiness checklists, identifying risks and developing mitigation strategies, building quality issue storyboards, providing study team assistance & support during inspection and post inspection/audit tasks (responses, CAPA, lessons learned)
• Coordinate and support identification and management of quality risks, including mitigation of risks and communication of significant risks to management
• Support relevant Leadership Team in the strategic direction and priorities of the group and to develop clinical quality related objectives and strategies that drive a culture of quality, including communications and critical issues
• Develop and implement continuous improvements by collating including reporting quality related trends and metrics periodically, escalating where necessary, and tracking related activities.
• Maintain current knowledge and awareness of regulations / guidance as well as any internal processes pertaining to clinical trials; provide interpretations of regulations and assessing impact on our systems and providing recommendations, where necessary.
• Provide quality and compliance support to assigned functional areas within Clinical Operations and R&D pertaining to the above.
• Assist in creation and maintenance of tools and processes to proactively address readiness for internal and regulatory GCP/GXP audits and inspections and development/maintenance of other tools and processes to support and enhance the above responsibilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director