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

AstraZeneca•Durham, NC

7d•Hybrid

About The Position

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.

Requirements

University degree (Bachelors' degree minimum) in related discipline preferably in life science or equivalent qualification aligned to the knowledge skills of role ensures successful conduct responsibilities appropriate interactions internal external stakeholders.
10+ yrs experience mastery Clinical Development area.
Role-relevant knowledge ability apply role responsibilities including but not limited: Drug development process related GxP processes international guidelines ICH-GCP relevant country regulations medical knowledge ability learn relevant AZ Therapeutic Areas Clinical Study Management Strategic portfolio management Functional management resourcing budget planning functional level activities Workforce planning collaboration leadership implement company objectives drive business outcomes Previous experience working site management organisation country regional global level understanding learning styles needs R&D professional.
Personal Effectiveness & Drives Accountability in Others
Learning Agility
Previous experience of working in a site management organisation at a country, regional or global level and an understanding of the learning styles and needs of the R&D professional
Proven line management expertise
Financial, Technology & Process Competency
Strong collaboration skills and ability to work in a matrix environment and influence others without authority.
Strong relationship-building, resourcefulness, and organizational skills.
Excellent communication skills coupled with Active Listening, Fluency in written & spoken business-level English
Act with Integrity & high ethical standards
Effective and adaptive team leadership, including cross-functional, virtual and global environments & demonstrate cultural awareness
Identify and champion more efficient delivery of quality clinical trials with optimised cost and time.
Ability to travel nationally/internationally as required.
Ability to drive and champion global change and actively advocate and implement more efficient and effective ways of working, learning and developing
Communication & Teamwork –Storytelling, Influencing, Business Acumen, Collaboration
Scientific Concept & Research Design: Industry Awareness
Effective, risk-based thinking –Problem Solving, Critical Thinking, Decision Making, Strategic Thinking, Effective Issue Management
Ethical & Participant Safety Considerations: Participant Safety Oversight and Reporting
Clinical Study Operations (GCP) & Quality Management - Audit & Inspection Readiness, Process Management & Improvement, RBQM: Interpreting and implementing the Monitoring Plan
Deliver Priorities Results & Impact - Empowerment & Delegation, Drive Results, Cultivates Innovation
Leadership – Enable Change, Feedforward & Coaching, Drives Vision & Purpose, Drives Engagement & Development, Building Effective Teams, Values Difference, Manages Conflict
Ability to assess organisational needs and develop a strategy to deliver to these, adjusting for organisational change and feedback
Experience in working successfully and collaboratively with external partners

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 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.
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, BioPharma.
Liaise with internal and external stakeholders, including Biopharma ClinOps Process, Quality, Learning, CDI, CSI, Global Oncology R&D SMM, and QA, to ensure SMM BioPharma is aligned with the company’s strategic quality objectives.
Lead and manage the activities of SMM Regional Clinical Quality Directors, ensuring a coordinated approach.
Collaborate closely with Regional SMM Directors to deliver all quality-related activities, and work with Study Management Functional Process Experts to resolve cross-functional quality challenges and opportunities.
Provide high-level compliance and process advice to SMM BioPharma and its Leadership Team, in collaboration with Biopharma ClinOps Process, Quality, Learning and Quality Assurance.
Ensure a comprehensive training strategy is developed and maintained to support high performance, in coordination with Biopharma ClinOps Process, Quality, Learning and Study Management.
Maintain up-to-date knowledge of international regulations, legislation, guidelines, standards, and sector practices, providing expert advice on adjustments to internal processes where required – particularly those relating to investigational sites and study monitoring.
Partner with SMM business leaders to conduct effective learning diagnosis of business and learner needs and translate into actionable development strategy and learning plans.
Development and Ownership of the SM&M Capability Framework and associated tools, including organizational engagement and change management. Conducts organizational gap analysis and sets quality, capability, process learning priorities with Global SMM LT.
Oversee the global SMM onboarding approach leveraging HR global onboarding tools R&D foundational materials to ensure an impactful seamless experience for new employees.
Identify clear measures of learning outcomes for specific learning interventions learning key performance indicators for SMM. Build insightful reports analyses for leadership that demonstrate return on investment for learning activities.
Maintain targeted resources to meet SMM priorities needs including oversee the SMM content on AZ Degreed learning platform; responsible for maintaining updating content to meet current future business needs. Align with R&D/AZ approach to ensure a positive seamless learner experience.
Represent SMM on R&D wide L&D Functional Learning Leads team bringing a strong voice of business to evolve R&D learning strategy pulling through R&D L&D frameworks initiatives for business benefit.
Strengthen build L&D capability in function by active participation in R&D Learning Guild (R&D Community of L&D Practitioners) support capability development of L&D technical staff involved in delivering learning solutions.
Work with global HR T&D Global Learning Services (GLS) curate upload content into relevant learning technology platforms following AZ standards best practices.
Commission oversee design build learning content with preferred external strategic partners vendors institutions ensure delivery agreed business specifications.
Actively engage learner audience conducting regular voice employee exercises leveraging social platforms (e.g., workplace) organizing facilitating learning engagement activities.
Keep abreast current trends R&D clinical research learning development practices keep technical learning current fresh engaging modern employee. Bring innovative approaches functional learning activities recommendations L&D development across SMM.
In cooperation Global Head Clinical Quality Management SMM BioPharmaceuticals R&D SMM Process Learning Lead & BioPharma Clinical Operations Learning team align mandatory procedural Training Strategy with SMM Capability Learning Development priorities seamless effective learner experience.