QuidelOrtho · 2 hours ago
Senior Program Manager
Rochester, NY
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $175K/yr
10+ years expQuidelOrtho is a leading in vitro diagnostics company that combines the strengths of Quidel Corporation and Ortho Clinical Diagnostics. The Senior Program Manager is responsible for managing complex programs and projects across multiple functions within the medical diagnostics portfolio, ensuring alignment with business priorities and delivering high-impact results in a regulated environment.
Medical Device
No H1B
Responsibilities
Leads the planning, execution, and delivery of medium to large-scale, complex programs, ensuring scope, schedule, and budget adherence
Coordinates efforts across R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance & Marketing to ensure program success
Develops detailed project plans, timelines, and resource allocations
Monitors progress and proactively address issues and risks
Facilitates regular communication with internal stakeholders, providing updates, resolving conflicts, and ensuring alignment
Ensures all program activities comply with relevant regulatory standards (e.g., FDA, ISO, etc.). Maintains accurate documentation and audit readiness
Translates business strategy into actionable program plans
Develops roadmaps, defines milestones, and manages interdependence across functions including R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance, and Marketing
Serves as the primary liaison between executive leadership and program teams. Facilitates communication, manages expectations, and ensures transparency across all levels of the organization
Identifies potential risks and implements mitigation strategies. Leads change management efforts to ensure successful adoption of program outcomes
Establishes program governance structures. Provides regular updates to senior leadership, including dashboards, KPIs, and executive summaries
Champions best practices in program management. Drives process improvements and contributes to the evolution of the business portfolio
Perform other work-related duties as assigned
Qualification
Required
This position is not currently eligible for visa sponsorship
Bachelor's degree in engineering, Life Sciences, Business, or related field; advanced degree preferred
PMP, PgMP or similar certification required
10+ years of experience in program/project management, preferably in medical devices, diagnostics, biotech, or healthcare technology
Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira)
Proven track record of leading extraordinarily complex programs with cross-functional teams in a regulated environment (e.g., FDA, ISO, etc.)
Strong business acumen, highly analytical, and strategic thinking
Exceptional communication (verbal & written), negotiation, and influencing skills
Ability to summarize complex project and technical subject matter into concise oral and written communications to Executive Management and C-Suite Leadership
Knowledge of timeline and budget management, manufacturing design transfer, Risk Management & Design Control
General knowledge of R&D, Regulatory, Clinical Affairs, Quality and Operations activities as they relate to the development of a medical device or product
Demonstrates the ability to lead the program team from inception to product launch using corporate design control processes and procedures. Is able to tailor the design control processes & procedures to fit the specific project needs and circumstances
Ability to work cohesively with multi-disciplinary scientific working groups
Must be able to lead, manage, and communicate action items and results from and in meetings in a logical fashion
Excellent prioritization, organization, and the ability to multitask
Develop project execution strategy with the ability to independently manage ambiguity
Experience in QSR (Quality System Regulations) and ISO medical device standards as well as a working knowledge of current FDA, IVDD, and other regulations
Recognized as a subject matter expert coupled with broad and deep knowledge of program management practices
Works independently with minimal guidance; influences across functions and levels
Leads initiatives with significant business impact
Solves complex problems requiring innovative thinking and cross-functional collaboration
Benefits
Medical
Dental
Vision
Life
Disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off (including sick time)
Paid Holidays
Company
QuidelOrtho
> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Joe Busky, CPA
Chief Financial Officer
Michael Iskra
Executive Vice President and Chief Commercial Officer
Recent News
2025-12-18
2025-11-06
2025-11-06
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