Director, Data Insights & Innovation

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

Position Summary

Reporting to the SVP, Quality we are seeking a transformational leader to drive QuidelOrtho's Quality organization into a digitally enabled, insight-driven function. This role is accountable for governance of quality IT platforms, data strategy, and end-to-end data analytics that empower smarter decisions, operational excellence, and continuous improvement across the enterprise. The Director will also oversee Computer System Validation (CSV) and cybersecurity-related quality processes, ensuring regulatory compliance and platform integrity.

Key Responsibilities

• Lead governance of enterprise Quality IT platforms (eQMS, LIMS, data lakes, dashboards) ensuring reliability, scalability, and compliance
• Establish and maintain global data governance framework for quality, ensuring data integrity and consistency
• Define enterprise quality data strategy aligned with corporate digital strategy and regulatory expectations
• Design and deliver data packages for Management Review providing timely, actionable quality insights
• Develop tools and reporting systems for daily management of quality performance (KPIs, dashboards, leading indicators)
• Lead end-to-end analysis of quality data across the product lifecycle connecting insights to risks and opportunities
• Enable predictive and advanced analytics to detect quality signals early and guide proactive risk management
• Own Computer System Validation (CSV) process for quality systems ensuring FDA, EMA, and global regulatory compliance
• Provide governance for cybersecurity-related quality processes protecting systems and data
• Drive harmonization of metrics, dashboards, and reporting across the enterprise
• Build and lead high-performing team specializing in data analytics, IT governance, and CSV/cyber quality oversight

Qualifications

Location: Must be within a 50-mile radius of a North America QuidelOrtho site:

• San Diego CA, Carlsbad CA, Pompano Beach FL, Raritan NJ, Rochester NY, Athens OH, Memphis TN, or Markham Ontario CAN

• Travel: 20%

Required:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related discipline
• 12+ years progressive experience in Quality, IT Governance, or Data Analytics within Medical Device/IVD/Biopharmaceutical industries
• Mastery-level knowledge of CSV, FDA Data Integrity principles, GAMP 5, and cybersecurity frameworks
• Proven experience managing enterprise IT platforms and digital systems in regulated environments
• Demonstrated success implementing data governance frameworks and analytics strategies
• Strong analytical and problem-solving skills with track record addressing complex challenges through data-driven insights
• Effective leadership skills with experience leading global, cross-functional, and matrixed teams
• Strong influencing and communication skills engaging senior stakeholders across diverse functions

Preferred:

• Advanced degree (MS, PhD, or PharmD)

Salary Transparency

Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. Salary range for this position is $150,000 to $190,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected].

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