The Role

The Senior Project Manager is a mid-level individual contributor responsible for managing defined projects and supporting broader programs within the medical diagnostics portfolio. This role ensures effective planning, coordination, and execution of project activities across functional teams. The Senior Project Manager plays a key role in driving project success through collaboration, problem-solving, and process discipline.

The Responsibilities

Leads the execution of assigned projects within larger programs, ensuring delivery on time, within scope, and within budget.
Collaborates with teams across R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance & Marketing to align project activities and helps resolve issues.
Develops and maintains detailed project plans, timelines, and resource forecasts. Tracks progress and adjusts plans as needed.
Identifies project risks and issues early while working with stakeholders to develop mitigation and resolution strategies.
Maintain accurate project documentation and provide regular status updates to program leadership and stakeholders
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 senior 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.
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.
Performs other work-related duties as assigned.

The Individual

Required:

Bachelor’s degree in engineering, Life Sciences, Business, or related field.
PMP certification required or equivalent demonstrated capability.
7+ 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).
Proven track record of leading 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.
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.
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.
Travel: Must be willing to travel up to 10% domestic and international.
This position is not currently eligible for visa sponsorship.

Key Working Relationships

Internal Customers:

Finance on budgeting and resource planning.
Clinical Affairs for project deliverables.
Quality Assurance for project activities, design transfer and risk management.
Senior Management on project reporting and planning.
Interacts with Marketing on project deliverables.
Regulatory and Clinical Affairs on project deliverables and planning.
Operations and R&D

External Customers:

Third-party vendors and suppliers
Project-specific development partners

The Work Environment

The work environment is a combination of laboratory, manufacturing, office, & remote home office.

The Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials is required. 60% of time in meetings, working with team, or talking on the phone, 40% of the time at the desk on computer, doing analytical work. Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel.

Salary Transparency

The 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. The salary range for this position is $135,000 to $165,000. 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.

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Ortho Clinical Diagnostics

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Senior Project Manager