AstraZeneca · 1 day ago
Associate Director, Clinical Quality
Durham, NC
Full-time
Hybrid
Lead/Staff, Director/Executive
5+ years expAstraZeneca is a global biopharmaceutical company, and they are seeking an Associate Director, Clinical Quality to help set strategic direction across R&D. The role is accountable for developing and delivering digital solutions that enhance clinical trial quality and ensure compliance across the organization.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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)
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
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
Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
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