Associate Director, Clinical Quality

AstraZeneca•Durham, NC

6d•Hybrid

About The Position

The role is responsible for supporting quality partnering across BioPharmaceuticals R&D, providing data-driven insights to inspection readiness, regulatory compliance, and empowering study teams to deliver clinical studies. The Associate Director, Clinical Quality is responsible for facilitating the delivery of Quality Management activities related to Clinical Operations within R&D working with partners 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, and collectively developing compliance focussed improvements to R&D processes.

Requirements

Bachelors degree in related discipline (preferably in life science), higher degree in a scientific or business discipline is desirable
4+ years of in depth proven experience in a clinical compliance or quality related position with a track record of success in leading quality and compliance activities
Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements.
Proven project management skills

Responsibilities

Establish and maintain effective systems and processes to support key performance areas for the function & wider organisation to maintain Quality Management excellence.
Work closely with colleagues and collaborators to support quality assurance and regulatory adherence initiatives. Promote a culture of quality across R&D as a quality champion.
Provide advice and standard process guidance on GCP or other relevant regulatory standards (such as GCP for labs, 21 CFR Part 11, etc.) for quality events, initiatives and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes).
Where vital, provide support to collaborators to ensure appropriate root cause analysis is conducted and CAPA plans (and in some cases, effectiveness check plans) are defined. Assist business function(s) with CAPA effectiveness checks.
Assist assigned partners and collaborators as they prepare for regulatory inspections (where vital)
Support identification and management of quality risks, including mitigation of risks and communication of significant risks to management.
Assist with relevant quality related communications and customer concerns.
Assist with identifying and implementing continuous improvement opportunities by ongoing review of quality related trends and metrics..
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 vital.
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 audits and inspections and development/maintenance of other tools and processes to support and improve the above responsibilities.