Strategic Operations Project Manager

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 Strategic Operations Project Manager. The Strategic Operations Project Leader develops strong business proposals and leads complex, cross‑functional projects that improve the efficiency, scalability, and regulatory strength of operations. This role manages strategic initiatives across product changes, process optimization, technology upgrades, and multi‑site improvements while driving change management and continuous improvement. The ideal candidate excels at influencing without authority, challenging the status quo, and aligning diverse stakeholders across multiple manufacturing sites.

This position is in Rochester, NY (Limited Remote)

What You’ll Do

1. Lead Complex, Cross-Functional Projects

• Manage a portfolio of strategic operational improvement projects tied to efficiency, manufacturing scalability, and product lifecycle changes.

• Drive cross‑functional planning, execution, risk management, and decision-making across multiple manufacturing locations.

• Apply strong project management discipline to keep teams aligned, on track, and accountable.

2. Build Robust Business Justifications & Influence Leadership Decisions

• Develop clear, data-driven business cases for proposed projects or changes, including cost–benefit analysis, ROI, risk assessment, resource needs, and strategic alignment.

• Translate technical and operational opportunities into compelling narratives that resonate with senior leadership.

• Present recommendations, tradeoffs, and decision options to executive stakeholders in a way that enables fast, informed decision-making.

• Support annual planning by providing well‑structured rationales for project prioritization and investment needs.

3. Enable Operational Efficiency & Continuous Improvement

• Identify, challenge, and streamline inefficient processes across sites and functions.

• Apply Lean/CI methodologies to simplify workflows, reduce waste, and improve throughput.

• Translate operational problems into structured plans with clear milestones, KPIs, and success criteria.

4. Navigate Regulatory & Quality Requirements

• Ensure project execution aligns with medical device regulatory expectations, including design control, change control, validation, and documentation standards.

• Partner with Quality and Regulatory teams to ensure compliance without sacrificing execution speed.

5. Drive Organizational Alignment & Change Adoption

• Act as a change agent—articulating the “why,” aligning stakeholders, and helping teams adopt new processes and ways of working.

• Facilitate communication across functions and leadership levels, ensuring transparency and proactive issue escalation.

• Influence stakeholders toward data‑driven decisions and standardized operational practices.

6. Support Multi-Site Collaboration

• Work across several manufacturing facilities to harmonize processes, share best practices, and elevate operational performance.

• Build trust and productive working relationships across geographically dispersed teams.

Required:

• Bachelor’s degree in engineering, science, operations, or related field.

• 7+ years of project/program leadership experience in regulated industries.

• Experience leading complex cross-functional initiatives.

• Strong knowledge of design/change control and regulated operations.

• Strong change management and influencing skills.

• Experience applying Lean/CI methodologies.
  ​

Preferred:

• Advanced degree (MBA, MS, etc.).

• PMP or Lean/Six Sigma certification.

• Multi-site manufacturing experience.

Internal: Operations, Manufacturing, Quality, Regulatory, R&D, Supply Chain, Site Leadership

External: Key Suppliers, Equipment/Technology partners

The work environment characteristics are representative of a typical office environment with some time in a manufacturing/production floor, lab, or warehouse. Travel up to 10%.

Up to 75% of the time you will be standing, walking or sitting Other physical demands include bending, crawling, stooping, vision, grasping, climbing or balancing, kneeling, crouching, talking or hearing, tasting or smelling.

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 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 $117,000 to $153,000 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.

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].

#LI-SP1