Senior Program Manager Full Cycle Product Development

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a worldleading in vitro diagnostics company with awardwinning 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

As we continue to grow as QuidelOrtho we are seeking a Sr. Program Manager to manage multiple projects across multiple platforms ranging in complexity to develop and release changes to products from Phase 0 approval to product market introduction. Develops project resource capital and expense estimates maintains timeline and deliverables of the project core team manages resource needs cross functional team(s) and thirdparty developers ensuring customer needs are met within schedule and budget. This role functions interchangeably as a participant or as a leader on teams responsible for changing SOPs Technical Files contacts training and issues related to the role.

This will be an onsite role at our San Diego Ca location.

The Position

• Leads cross functional project teams. Holds regular meetings and holds team members accountable to project goals. Works with staff to draw realistic but challenging timelines/priorities and provides followup/support on their timely
• Responsible for coordinating team activities in accordance with Design Control New Product Development Guidelines and Risk Management. Responsible for the timeline and design history file for the project
• Works with functional areas to estimate expenses and track budget. Supervises and supports development of Design and Development Plan Risk Management Plan and Report FMEA Master Validation Plan and other required documentation. Trains other employees in new assays and systems
• Collaborates with key stakeholders (e.g. Sales Marketing Technical Support Regulatory Affairs and Quality Assurance) to ensure changes meet crossfunctional needs
• Attracts retains and motivates a high caliber team
• Leads teams that are necessary to complete required changes including: SOPs training systems support and development labeling processes for product launch in the EU supports efforts to manage Economic Operators and other duties
• Participates in internal auditing and training systems to ensure compliance with the quality system
• Perform other workrelated duties as assigned

The Individual

Required:

• Bachelors degree (BS/BA) in a Biological Science Mechanical Electrical / Electronic Biomedical or Systems Engineering
• Minimum of 7 years of related experience in program management.
• 3 years in a medical device or related field.
• PMP certification required
• Has demonstrated experience in managing projects.
• Requires strong written and oral communication skills and good analytical skills. Ability to communicate to Executive Management.
• Knowledge of timeline and budget management manufacturing design transfer Risk Management and Design Control. Responsible for Design Control and the Design History File.
• General knowledge of R&D Regulatory Quality and Operations activities as it relates to development of a medical device
• Strong knowledge of quality systems in a manufacturing environment
• Working knowledge of current FDA IVDD and other regulations
• Ability to work cohesively with multidisciplinary scientific working groups
• Excellent written verbal and interpersonal skills to influence many diverse internal/external customer groups
• Must be able to lead manage and communicate action items and results from and in meetings in a logical fashion.
• Project management experience is required including proficiency with project tools such as GANTT and PERT charts MS Project and other tools
• Excellent project management skills
• Excellent prioritization organization and the ability to multitask
• Experience in QSR (Quality System Regulations) and ISO medical device standards
• Excellent communication skills (verbal and written)
• Strong leadership skills and the ability to foster strong interpersonal relationships between groups
• This position is not currently eligible for visa sponsorship.

The Key Stakeholders

Internal Partners:

• Supply Chain manufacturer technical support quality Assurance Sales and Marketing Clinical Affairs Regulatory Affairs Operations and Marketing/Finance.

External Partners:

• Contractors and vendors.

The Work Environment

The work environment characteristics are representative of a manufacturing laboratory or warehouse environment and include handling of viral and bacterial hazards potentially hazardous chemicals as well as infectious or potentially infectious bodily fluids tissues and samples. Up to 75 of the time at desk standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

No strenuous physical activity though occasional light lifting of files and related materials is required. 30 of time in meetings working with team or talking on the phone 70 of the time at the desk on computer doing analytical work. Minimal 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 the facts and circumstances of each case. The salary range for this position is $130000$145000 and is bonus eligible or eligible for incentive compensation. 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 noncontractual 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 .