Senior Director, Quality System Excellence

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 dynamic, strategic leader to develop and deploy our future Quality Management System strategy. This role will transform our system and organizational capabilities to ensure QuidelOrtho's Right to Operate while enabling the business to adapt with speed and confidence in a rapidly evolving environment.

Key Responsibilities

• Lead and ensure compliance of the Global Quality Management System across all sites with applicable regulatory requirements
• Establish inspection readiness and manage responses to Health Authority observations
• Provide leadership to multi-level global Quality Management System functions
• Partner with Business Units, Global Functions, and Regional organizations on strategic quality initiatives
• Develop and manage annual budgets while monitoring expenditures for efficient resource utilization
• Champion continuous improvement and lean leadership principles throughout the organization
• Build and develop high-performing teams with clear succession planning

Qualifications

• Location: Must be within a 50-mile radius of a US QuidelOrtho site: San Diego CA, Carlsbad CA, Pompano Beach FL, Raritan NJ, Rochester NY, Athens OH, Memphis TN
• Travel: 20%

Required:

• Bachelor's or Master's degree in Life Sciences, Pharmacy, or related field
• 15+ years in Medical Device/Pharmaceutical/Biopharmaceutical industry
• Minimum 5 years in Quality, Compliance, Regulatory, and/or Validation
• 8+ years of people leadership experience, including leading leaders
• Extensive knowledge of QMS and cGMP regulations (European, U.S., China, international)
• Proven experience with Health Authority inspections

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 $230,000 to $280,000 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 recruiting@quidelortho.com.

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