Senior Manager, TM Testing
About The Position
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. As we continue to grow as one QuidelOrtho we are seeking a Senior Manger, TM Testing. The Senior Manager Clin Labs Testing (or TM testing) is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality Control—ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The Quality & Compliance Senior Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Quality & Compliance Senior Manager ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be onsite in Pompano Beach, Florida.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
- 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership.
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- Proven ability to lead and develop high-performing teams and build future technical and people leaders.
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
- Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
- Experience leading in a matrixed, global organization and managing competing priorities effectively.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
Nice To Haves
- Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.
- Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.
- Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.
- Experience supporting or leading Health Authority or Notified Body inspections.
Responsibilities
- Lead and oversee quality control (QC) release testing operations across multiple global locations supporting the Transfusion Medicine line of business.
- Ensure that all release testing activities are executed in compliance with global regulatory requirements, quality system standards, and internal procedures, enabling the timely and compliant release of IVD products to market while also supporting business growth and product lifecycle activities.
- Accountable for developing talent, strengthening scientific and compliance capabilities,
- Perform other work-related duties as assigned.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
