Senior Director, Global Quality and Operational Excellence, Site Management & Monitoring

Senior Director, Global Quality and Operational Excellence, Site Management & Monitoring

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Job Title: Senior Director, Global Quality and Operational Excellence, Site Management & Monitoring

Location: Durham, NC

Are you ready to lead the charge in transforming clinical operations? As the Senior Director of Global Quality and Operational Excellence for Site Management & Monitoring (SMM) at AstraZeneca, you ll be at the forefront of shaping our quality, capability, and learning vision. This pivotal role provides strategic direction and global oversight, ensuring our clinical trials are conducted with the highest standards of compliance and innovation.

Reporting directly to the VP and Global Head of SMM, Bio Pharma R&D, you ll develop and execute plans that drive effective quality and risk management across all SMM Bio Pharma countries.

• Oversee the quality and compliance of SMM activities across all countries, ensuring adherence to ICH-GCP, local laws and regulations, and AstraZeneca’s global processes. Responsible for quality metrics across SMM and identifying early trends.
• Maintain industry standard process awareness and up-to-date knowledge of international standards, regulations, and guidelines relevant to SMM activities.
• Proactively identify, analyze, and manage global quality and compliance risks within SMM.
• Support development of effective and consistent risk mitigation strategies for global quality risks, coordinating these activities at the regional level.
• Oversee SMM-related quality issue management processes, including handling potential and confirmed serious breaches and CAPAs, ensuring global trend analysis and appropriate follow-up.
• Provide first-line quality support for SMM, including audits and inspections – engaging with wider quality functions within R&D to enable effective responses and support for SMM.
• Drive and promote risk-based, innovative approaches to quality management within SMM.
• Promote the sharing of continuous improvement initiatives and lessons learned relating to quality and compliance across SMM.
• Work closely with Biopharma Clin Ops Process Quality & Learning and Global Clinical Solutions (GCS) functions to ensure the development and implementation of robust processes, templates, guidelines, SOPs, tools, and systems that comply with ICH-GCP and all applicable requirements.
• Serve as key interface between SMM and Business Process Management Organization (BPMO).
• Liaise and collaborate with Biopharma Clin Ops Process, Quality, Learning, and GCS, ensuring provision of expert SMM operational input and user requirements reflected in all AstraZeneca global systems and processes, supporting their effective implementation within SMM. Act as a change agent to support uptake and adoption of new and revised processes.
• Actively participate as a member of the SMM Bio Pharma Leadership Team.
• Support the execution and optimization of AstraZeneca’s digital strategy by providing quality oversight and highlighting areas of risk that require management.
• Drive innovation in quality management within SMM by promoting the use of digital solutions and maximizing the utilization of data available within AstraZeneca systems.
• Foster collaboration on projects involving other AstraZeneca functions, particularly BPMO, GCS, Centralized Monitoring, and Study Management, and work closely with Oncology R&D SMM for cross-disciplinary initiatives.
• Coordinate inspection readiness activities across SMM, promoting consistent standards and approaches within all Clinical Operations functions.
• Collaborate with Quality Assurance (QA) to ensure SMM input into audit strategies and to secure QA support for inspections, encouraging effective interactions with QA Strategic Advisors at all levels.
• Monitor, analyze, and act upon SMM quality metrics and KPIs, driving continuous process and quality improvement.
• Provide transparency and robust oversight of the quality status to the Global Head, SMM, Bio Pharma.
• Liaise with internal and external stakeholders, including…