Senior Manager, Data Analytics

Job Description

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

Pay Range: $106,200 - $149,000/ year

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

• Medical/Prescription Drugs
• Dental
• Vision
• Flexible Spending Accounts (FSAs)
• Supplemental Health Plans
• 401(k) Plan - Company match dollar-for-dollar up to 5%
• Employee Stock Purchase Plan (ESPP)
• Supplemental Life Insurance
• Dependent Life Insurance
• Short- and Long-Term Disability buy-up
• Blueprint for Wellness
• Emotional Well-Being Resources
• Educational Assistance
• Paid time off / Health Time
• Variable Compensation Plans
• Sales Incentive Plans

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Master Control, SAP, Veeva, Medialab, Smartsolve, etc.

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

• 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).

Bachelor's Degree (Required)

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