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

Role Summary

Senior Director, Global Quality and Operational Excellence for Site Management & Monitoring (SMM) at AstraZeneca. Location: Durham, NC. Provides strategic direction and global oversight to drive high standards of quality, compliance and risk management across SMM BioPharma countries, delivering a global learning strategy and ensuring consistent, data-driven quality management across regions and study portfolios.

Responsibilities

• 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 ClinOps 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 BPMO; liaise and collaborate with Biopharma ClinOps Process, Quality, Learning, and GCS to reflect user requirements in global systems and processes, supporting effective implementation and change adoption.
• Actively participate as a member of the SMM BioPharma Leadership Team; support digital strategy with quality oversight and risk management input; promote the use of digital solutions and data utilization.
• Foster collaboration on cross-functional projects with BPMO, GCS, Centralized Monitoring, Study Management, and Oncology R&D SMM; coordinate inspection readiness across SMM and collaborate with QA to secure QA support for inspections.
• Monitor, analyze, and act upon SMM quality metrics and KPIs to drive continuous improvement; provide transparent oversight of quality status to senior leadership.
• Lead and manage regional Clinical Quality Directors and collaborate with Regional SMM Directors to deliver quality-related activities and resolve cross-functional challenges.
• Ensure comprehensive training strategies to support high performance; maintain up-to-date knowledge of regulations and industry practices; translate learning needs into actionable development plans.
• Develop and own the SM&M Capability Framework and related tools; oversee onboarding and learning outcomes measurement; manage content on learning platforms and engage learners through various channels.
• Represent SMM on R&D L&D initiatives; participate in external learning communities to build internal capability and align with AZ learning standards.
• Coordinate with HR T&D GLS and external partners to design, develop, and deliver learning content that meets business requirements.
• Engage learners and drive innovative L&D approaches; keep learning practices current and impactful across SMM.
• Align mandatory procedural training with SMM capability priorities and ensure effective learner experiences across the organization.

Qualifications

• Required: University degree (Bachelor’s) in a life science or related discipline; relevant qualification aligned with role responsibilities.
• Required: 10+ years of experience in Clinical Development or a closely related field.
• Role-relevant knowledge includes drug development processes, GxP, ICH-GCP, and understanding of regulatory requirements across multiple regions; experience with site management at country, regional, or global levels; familiarity with learning and development in R&D.

Skills

• Personal effectiveness and accountability; strong learning agility.
• Proven line management experience; ability to lead cross-functional, virtual, and global teams; strong collaboration and influence without authority.
• Excellent communication, active listening, and business English proficiency; high ethical standards.
• Strategic thinking, risk-based decision making, and problem solving; ability to drive change and process improvements.
• Ability to travel nationally/internationally as required; strong relationship-building and organizational skills.
• Knowledge of RBQM, study monitoring, audit and inspection readiness, and quality management in clinical trials.

Education

• Bachelor’s degree in life sciences or related field.

Additional Requirements

• Ability to travel nationally/internationally as required.
• Willingness to engage in global, cross-functional initiatives and adopt new processes and digital tools.