Associate Director, Clinical Quality

AstraZeneca•Durham, NC

8h•Hybrid

About The Position

The Clinical Quality Associate Director helps set strategic direction across R&D. They provide comprehensive Quality Management support services. They embed quality and compliance “Right From Me” and ensure ongoing proactive inspection readiness. The Associate Director, Clinical Quality is accountable for developing and delivering digital solutions that reduce manual quality efforts. They also maintain these solutions and deploy innovative tools to track inspection readiness and clinical quality across the organization. The role develops and enhances best practices for quality and compliance; contributes to vendor oversight to uphold quality agreements and performance across R&D; maintains strong internal and vendor networks to promote quality compliance and inspection readiness; contributes to the Study Quality Oversight strategy and roadmap, serves as the lead for its technical development, and uses enterprise R&D insights and signals to proactively mitigate future quality and inspection risks and to embed a culture of quality and compliance across the organization. Accountabilities/Responsibilities: Builds, presents, and sustains metrics & reporting on the Study & Quality Oversight (SQO) roadmap (Power BI) ensuring effective achievement of analytics goals Develops, delivers and maintains automated tools, workflows, and processes leveraging Microsoft Power Platform (Power BI, Power Automate, Power Apps) and/or equivalent tools to reduce manual quality efforts and to enhance overall clinical trial quality and inspection readiness for global study teams and functions Guides partner engagements to gather requirements for reporting bringing together resources from across the organization Support Leadership in the strategic direction and priorities of the group. Contributes to objectives and strategies that drive a culture of quality. Helps in the development of Study Quality Oversight roadmap and strategy to drive a culture of quality Contributes to vendor oversight of quality compliance across R&D upholding quality agreements and partnerships with vendors Leads the development, enhancement and implementation of best practice concerning quality and compliance Leads development of successful and collaborative relationships and networks with key internal stakeholders Provides direct support for applicable inspections, audits, CAPAs, and effectiveness checks Provides clinical quality expertise to external partners. Participate in related governance and steering committees Maintains a network of relationships across R&D and our vendors to promote and support quality compliance and preparedness for inspections Collaborates to drive compliance and build in process quality (supporting a state of inspection readiness) Support driving and embedding a culture of quality and compliance Maintain awareness of existing and new internal and external regulations and guidance pertaining to GCP, ICH, data integrity, system validation etc. assessing impact and providing recommendations where required

Requirements

University degree in related field, preferably in life science or equivalent
5 plus years of experience, preferably in biopharmaceutical industry, in clinical development
Strong technical skills and experience in delivering digital solutions in the following areas: Analytics (Power BI, Sharepoint) Automation (Power Apps & Power Automate) AI/NLP (Python, SQL, LLMs)
Solid analytical, problem solving, negotiation and conflict resolutions skills
Significant experience in several Quality Management Services such as issue identification, improvements, trending, standardized quality metrics, compliance measures quality risks, inspection support, audit coordination, system validation, data integrity
Experience providing support for regulatory inspections and audits
Experience supporting risk identification and management of investigations and CAPA activities
Excellent understanding of the drug development process and related GxP activities
Understanding of the skills and knowledge required for the successful delivery of drug development project, e.g., ICH/GCP, Document Management, Process Management, Risk Management, System Validation methodology and documentation, Quality Metrics
Knowledge of international regulations
Experience in successfully leading or contributing to change initiatives
Solid analytical, problem solving, negotiation and conflict resolutions skills
Ability to collaborate proactively and deal with ambiguity
Ability to build strong customer relationships and strategic working partnerships across multiple domains to enable process and system harmonisation and standardisation.
Leadership skills promoting motivation and empowerment of others to accomplish individual, team and organisational objectives
Excellent written and verbal communication and influencing skills, negotiation, presentation, knowledge transfer (mentoring), collaboration, problem solving, conflict management and interpersonal skills
Proven leadership capability
Proven project management skills
Ability to empower a team and work effectively within a team in a fast-paced, ever-changing environment
Strategic & conceptual thinking, planning, and execution
Exceptional problem solver with ability to conceptualize future ways of work from assessments of the current state
Ability to manage change
Experience leading digital transformation initiatives (reporting, automated workflows and application development)
Ability to work collaboratively within a diverse environment (cultural sensitivity and diplomacy)

Responsibilities

Builds, presents, and sustains metrics & reporting on the Study & Quality Oversight (SQO) roadmap (Power BI) ensuring effective achievement of analytics goals
Develops, delivers and maintains automated tools, workflows, and processes leveraging Microsoft Power Platform (Power BI, Power Automate, Power Apps) and/or equivalent tools to reduce manual quality efforts and to enhance overall clinical trial quality and inspection readiness for global study teams and functions
Guides partner engagements to gather requirements for reporting bringing together resources from across the organization
Support Leadership in the strategic direction and priorities of the group.
Contributes to objectives and strategies that drive a culture of quality.
Helps in the development of Study Quality Oversight roadmap and strategy to drive a culture of quality
Contributes to vendor oversight of quality compliance across R&D upholding quality agreements and partnerships with vendors
Leads the development, enhancement and implementation of best practice concerning quality and compliance
Leads development of successful and collaborative relationships and networks with key internal stakeholders
Provides direct support for applicable inspections, audits, CAPAs, and effectiveness checks
Provides clinical quality expertise to external partners. Participate in related governance and steering committees
Maintains a network of relationships across R&D and our vendors to promote and support quality compliance and preparedness for inspections
Collaborates to drive compliance and build in process quality (supporting a state of inspection readiness)
Support driving and embedding a culture of quality and compliance
Maintain awareness of existing and new internal and external regulations and guidance pertaining to GCP, ICH, data integrity, system validation etc. assessing impact and providing recommendations where required