Senior Program Manager

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 6000 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

At QuidelOrtho were advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Program Manager. The Senior Program Manager is responsible for managing complex programs and projects that span multiple functions within the medical diagnostics portfolio. This role drives execution ensures alignment with business priorities and delivers high-impact results in a regulated environment. The Senior Program Manager leads cross-functional teams through influence and subject matter expertise.

This position will be located in Rochester NY onsite.

The 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.

The Individual

Required:

• This position is not currently eligible for visa sponsorship.
• Bachelors 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.

The Key Working Relationships

Internal Partners:

• 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 Partners:

• Third-party vendors and suppliers
• Project-specific development partners

The Work Environment

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

Physical Demands

No strenuous physical activity though occasional light lifting of files and related materials is required.

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 the facts and circumstances of each case. The salary range for this position is $150000 to $175000 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 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 the 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 .