Lead NA Aladdin Business Manager driving strategic projects on Aladdin for Columbia Threadneedle Investments. Manage stakeholder relations, operational oversight, and deepen Aladdin usage across the organization.
About the role
- Executive Director of Digital Quality leading a technical team at Gilead. Overseeing digital quality functions and driving digital transformation in health product systems.
Responsibilities
- Lead the digital quality function with full accountability for strategy, execution, and performance.
- Build and direct a diverse digital quality team; drive cross-functional collaboration with IT, manufacturing, regulatory, and supply chain
- Champion digital transformation (automation, AI/ML, advanced analytics) across all GMP quality activities, ensuring harmonization and standardization including SaMD, eQMS, and data platforms.
- Partner with senior executive leadership on strategic issues with Gilead-wide impact.
- Build collaborative relationships across functions and with external partners to drive innovation and compliance.
- Oversee, Develop and maintain the Quality Management System (QMS) for digital health products and GxP computerized systems.
- Ensure compliance with global regulatory requirements (FDA, EMA, ICH, GDPR, 21 CFR Part 11).
- Support Gilead inspections with a focus on GxP digital Compliance (CSV, Data Integrity etc.).
- Oversee validation lifecycle for systems such as Veeva Vault and LIMS.
- Define and execute the digital quality roadmap in partnership with IT, Clinical, Regulatory, and Product Development.
- Guide and integrate agile software development in a regulated environment.
- Lead risk assessments and CAPA processes for digital systems.
- Drive innovation through advanced technologies such as AI, machine learning, and data analytics.
- Provide expert guidance and training on digital quality principles.
- Mentor and develop talent, fostering a culture of inclusion, accountability, and continuous improvement.
Requirements
- Bachelor’s degree in a scientific, computer science, or engineering field
- 16+ years of relevant experience with a BS/BA, or 14+ years with an MS/MA, MBA, or PhD
- Proven leadership in digital quality, software validation, and regulatory compliance
- Strong cross-functional collaboration and strategic influence
- Excellent analytical, communication, and problem-solving skills
- Master’s degree or quality certifications (e.g., ASQ Certified Quality Engineer) preferred
- Experience with Veeva Quality Suite or similar eQMS platforms, and SAP preferred
- Familiarity with AI, machine learning, and data analytics in a GxP environment preferred
- Knowledge of agile software development methodologies preferred
- Mastery of GMP, quality systems, Computer Validation and Data Integrity preferred
- Visionary ability to implement disruptive technologies at scale preferred
- Data-driven approach to risk, trends, and process optimization preferred
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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