Senior Manager, Data Analytics

Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function.

This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting.

This is a highly visible position with responsible for preparing content, insights and reports in support of Board of Director meetings/request for data and executive-level engagements.

Preference will be given to someone residing close to one of our Major labs in (Pittsburgh, Houston, Lenexa, Marlborough, Dallas, Wooddale, Tampa, Chantilly)

Work Schedule : Hybrid ( 3 days onsite, 2 days work from home)

Internal Grade : 51

Preference will be given to someone with regulated healthcare, life sciences, or diagnostics background.

***No sponsorship available***

Data Strategy & Architecture

• Design and maintain the QRA data analytics roadmap aligned with business objectives.
• Lead the development of dashboards, scorecards, and automated reports to track quality, regulatory, and compliance KPIs.
• Partner with IT and enterprise analytics teams to ensure data integrity, standardization, and scalability across platforms.

Governance & Board-Level Reporting

• Lead the design, validation, and delivery of high-impact visualizations and insights used in Board of Directors materials, executive summaries, and quarterly business reviews.
• Ensure analytical rigor and compliance in data presented to governance bodies.
• Collaborate with Regulatory Affairs, Legal, Compliance, and Enterprise Risk Management to ensure data reporting aligns with internal and external standards.

Advanced Analytics & Decision Support

• Apply statistical and predictive analytics to identify trends, risks, and opportunities across quality and regulatory operations (e.g., CAPA trends, audit findings, inspection readiness).
• Enable proactive decision-making through scenario modeling, root cause analysis, and risk-based prioritization.
• Provide strategic insights that inform QRA planning, operational initiatives, and performance improvement.
• Drive automation of data reporting to reduce costs, improve customer experience, and enhance data quality.

Stakeholder Collaboration

• Serve as a trusted advisor to QRA leadership, offering analytics expertise to drive quality and compliance decisions.
• Partner cross-functionally with Laboratory Operations, R&D, Clinical Affairs, and Corporate Functions to integrate analytics into key business processes.

Required WorkExperience:

• 8+ years of experience in data analytics, with at least 3 years in a regulated healthcare, life sciences, or diagnostics environment.
• 3+ year of experience preparing data-driven materials for governance, including Board of Directors or executive-level audiences.

Preferred Work Experience:

• Experience in Quality and Regulatory Affairs within the diagnostics, medical devices, or laboratory services industry.
• Experience working with artificial intelligence (AI)
• Working knowledge of enterprise systems such as MasterControl, SAP, Veeva, Medialab, Smartsolve, etc.

Knowledge:

• Familiarity with GxP, FDA, CLIA, and other relevant regulatory frameworks.

Skills:

• Proficient with SQL, Python, or R for data transformation and analysis.
• Proficient in data visualization and BI tools (e.g., Tableau, Power BI, Looker).
• Certified Analytics Professional, ASQ, RAC).

EDUCATION
Bachelor's Degree(Required)

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.