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

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

Location: Durham, NC

Introduction to role

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, BioPharma R&D, you'll develop and execute plans that drive effective quality and risk management across all SMM BioPharma countries. Are you prepared to make a difference?

About the role:

As a direct member of the SMM BioPharma Leadership Team, providing expert quality risk management insight to influence global strategy and key decision-making. The Senior Director drives innovation and promotes uniform, data-driven, and risk-based quality management practices across regions and study portfolios, ensuring all SMM countries operate to the same high standards of ICH-GCP and regulatory compliance.

This role works with and maintains strong, collaborative interfaces with key stakeholders ⎯ including SMM Executive Directors, Country Heads, TA Clinical Operations leaders, Clinical Quality Directors, BioPharmaceuticals Business Unit leaders Clinical Operations, Clinical Functional Partnering, Business Process Management & Optimisation, Clinical Data and Insights, Global Clinical Solutions, Global Oncology R&D SMM, Study Management Organisations (Early and Late), Quality Assurance, to ensure quality, process and regulatory compliance, and deliver a global learning strategy for the SMM organisation addressing the unique needs of a rapidly evolving, diverse SMM workforce. Global Quality, Capability, Learning & Development, plays a significant role in defining and supporting innovative solutions in highly complex business areas, and is recognised externally as a leading authority and subject matter expert in clinical quality management, skills and learning.

The Global Quality and Operational Excellence leader is a member of the Global SMM Leadership Team and works in partnership with the Biopharma ClinOps Process, Quality & Learning, and BioPharma Clinical Operations & Oncology Clinical Operations Leadership Teams, to ensure appropriate standardisation across all countries globally, thus ensuring a ‘One SMM’ mindset irrespective of TA alignment of staff.
 

Accountabilities

• 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 Business Process Management Organization (BPMO).

• Liaise and collaborate with Biopharma ClinOps Process, Quality, Learning, and GCS, ensuring provision of expert SMM operational input user requirements are reflected in all AstraZeneca global systems and processes, supporting their effective implementation within SMM. Act as a change agent to support effective uptake and adoption of new and revised processes.

• Actively participate as a member of the SMM BioPharma Leadership Team.