AstraZeneca · 10 hours ago
Senior Director, Global Quality and Operational Excellence, Site Management & Monitoring
Durham, NC
Full-time
Hybrid
Director/Executive
10+ years expAstraZeneca is a global biopharmaceutical company focused on delivering life-changing medicines. The Senior Director of Global Quality and Operational Excellence for Site Management & Monitoring will lead the charge in transforming clinical operations by providing strategic direction and oversight to ensure compliance and innovation in clinical trials.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
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
Benefits
Opportunities for lifelong learning
Career development
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
Company data provided by crunchbase