Senior Manager, TM Testing at QuidelOrtho

Pompano Beach, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

175000.0

Posted On

22 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Release Testing, People Leadership, Quality Systems, Regulatory Requirements, ISO 13485, FDA 21 CFR 820, IVDR, Talent Development, Compliance Capabilities, Data-Driven Decision-Making, Agile Leadership, Cross-functional Collaboration, Analytical Skills, Problem-Solving, Inspection Readiness

Industry

Medical Equipment Manufacturing

Description

The Opportunity 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. The Role 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. The 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. The Individual Required: 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. Preferred: 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. Key Interactions Internal: Tech Transfer, Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other Quality & Compliance teams globally and regionally External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. Work Environment The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. The Physical Demands No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. How We Work At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact: Thrive Together – Collaborate intentionally, grow as a team Make It Happen – Focus on priorities, embrace continuous improvement Commit to Service – Cultivate a service mindset Embrace Inclusion – Be open and authentic, welcome diverse perspectives 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 that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 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. #LI-SP1 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. Return to Job Search Important: Don’t see a current job opportunity that is just right for you? Take 2 minutes and create a custom job alert which will notify you when we post a position which matches your interests. It is quick and easy and will make your career search easier. or Visit the QuidelOrtho to learn about our solutions, products, and services. 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 job related 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 US QuidelOrtho EEO and AAP Policy Statement US Equal Employment Opportunity Posters

Responsibilities

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 business agility and growth. The role involves leading and overseeing quality control release testing operations across multiple global locations supporting the Transfusion Medicine line of business.