Senior Director, R&D Quality Transformation and Data Science

AbbVie is dedicated to delivering a consistent stream of innovative safe and effective medicines and products that solve serious health issues and have a remarkable impact on peoples lives. As a quality organization in research & development R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the products lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.

Patient needs stakeholder demands industry innovation regulatory landscape and AbbVies evolved business strategy are complex rapid pace and dynamic. Emphasizing and embedding quality in the execution of clinical trials post market vigilance and post market studies assures patient safety maintains data integrity fosters regulatory compliance and contributes to the overall success of drug/device development programs.

The Sr Director R&D Quality Transformation and Data Science is an enterprise leader driving transformation across R&D Quality Assurance integrating digital analytics (including AI/ML) and operational best practices. This role sets the strategic vision for optimizing quality processes data science and AI building insights from the Quality Beyond Compliance diagnostic survey and other organizational feedback to elevate quality culture streamline ways of working and accelerate innovation.

This position is suited for a transformative leader passionate about shaping R&D QAs futurenot just through technology and data science but through operational excellence and a commitment to quality culture informed by stakeholder insights. The role reports directly to the Vice President of R&D Quality Assurance and is a member of the R&D Quality Leadership Team. They are expected to role model performance leadership and behaviors (AbbVies Ways We Work) for the wider organization.

Primary responsibilities: 

• Develop own and continuously evolve the long-term strategy and roadmap for R&D QA transformationincluding advanced analytics AI/ML process optimization and operational excellenceanchored to organization-wide priorities regulatory requirements and diagnostic insights. 
• Evaluate and translate survey and diagnostic findings into prioritized change initiatives addressing root causes and opportunities for improvement in both quality culture and business operations.
• Lead high-performing multi-layered global matrixed teams (senior leaders directors managers and technical experts) to deliver advanced analytics enable digital transformation and reimagine processes across the R&D QA landscape.
• Champion investments and adoption of new technologies platforms and operating models that drive operational efficiency data-driven decision making and sustained quality improvement.
• Oversee alignment and execution of cross-functional enterprise-level analytics and transformation projects including resource planning budget ownership measurable outcomes and ongoing stakeholder engagement.
• Set policy and governance for data quality analytics compliance AI/ML usage and change management ensuring all enhancements meet regulatory and business standards.
• Advise senior leaders on risks impacts and opportunities related to QA transformation digital strategies and emerging regulatory trends.
• Build partnerships across IT R&D Regulatory and Business functionspromoting a culture of innovation collaboration and transparency.
• Represent R&D QA internally and externally advancing quality analytics process excellence and talent development.
• Promote continuous learning diversity and upskilling to support evolving business and digital needs.

Qualifications :

• Advanced degree in Data Science Engineering Quality Business Life Sciences or related discipline.
• 12 years progressive leadership in data science analytics AI/ML process transformation or operational excellence within life sciences or regulated industries including leadership of large multi-disciplinary global teams.
• 15 years industry experience across pharmaceutical medical device combination products research development clinical operations manufacturing quality systems or comparable experiences.
• Demonstrated success leading large-scale enterprise transformation initiatives leveraging advanced analytics digital/AI/ML technologies and survey-driven insights to impact quality and business outcomes.
• Deep expertise in R&D quality systems global compliance process optimization and digital innovation in regulated environments.
• Strong executive presence strategic vision budget/resource management and proven ability to lead and influence cross-functional teams.
• Outstanding communication change leadership and stakeholder management skills.
• Track record of delivering measurable business impact through process digital and analytics innovation.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time