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Job Description
Who is CorDx?
CorDx is a multi-biotech organization focused on innovation and supply in global health. With over 2,100 employees worldwide, serving millions in over 100 countries, CorDx provides rapid testing and point-of-care medical device solutions for detecting infectious diseases such as COVID-19, drugs of abuse, biomarkers, and more. The company is at the forefront of technology, artificial intelligence, and data science, aiming to deliver diagnostic solutions for critical healthcare questions.
Job Type:
Full-time Job Title:
Senior Project Manager Location:
Onsite - San Diego, CA Job Overview: We seek a highly motivated and experienced
Senior Project Manager
to lead cross-functional projects within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role manages projects from development to launch, ensuring goals, timelines, and budgets are met while aligning with company strategy and regulatory standards. The ideal candidate possesses strong project management skills, industry knowledge, and leadership abilities. Key Responsibilities: Manage cross-functional teams across R&D, Regulatory, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to commercialization. Develop and maintain project plans, schedules, and budgets, tracking milestones and dependencies. Report on project status, risks, and issues to stakeholders and leadership. Coordinate resources and prioritize tasks across departments for efficient project execution. Support regulatory submission activities, ensuring compliance with standards like FDA and ISO 13485. Facilitate project meetings, including updates, risk reviews, and issue resolution. Manage external vendors and partners involved in development and manufacturing. Contribute to process improvements in project management methodologies. Maintain project documentation and support governance processes. Requirements Qualifications: Bachelor’s degree in Life Sciences, Engineering, Business, or related field; advanced degrees preferred. 5-8 years of project management experience in biotech, diagnostics, or medical devices, especially in regulated environments. Understanding of regulatory pathways, quality systems (ISO 13485), and product commercialization for IVDs or medical devices. Proven ability to manage cross-functional teams and deliver projects on time and within budget. Experience in Life Science/IVD industry highly preferred. PMP certification or formal project management training strongly desired. Excellent organizational, leadership, and interpersonal skills. Ability to thrive in a dynamic, fast-paced environment with shifting priorities. Skills & Competencies: Experience supporting global product launches and managing distributed teams. Familiarity with project management software and tools. Exposure to Agile or Stage-Gate development methodologies. Strong problem-solving, decision-making, and critical thinking skills. Experience working with external partners and managing vendor relationships is a plus. Benefits: Comprehensive medical, dental, and vision insurance. 401(k) plan with company contributions. Flexible paid time off (PTO). Additional benefits. Equal Opportunity Statement:
We are an equal opportunity employer committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, marital status, or any other protected characteristic.
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Full-time Job Title:
Senior Project Manager Location:
Onsite - San Diego, CA Job Overview: We seek a highly motivated and experienced
Senior Project Manager
to lead cross-functional projects within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role manages projects from development to launch, ensuring goals, timelines, and budgets are met while aligning with company strategy and regulatory standards. The ideal candidate possesses strong project management skills, industry knowledge, and leadership abilities. Key Responsibilities: Manage cross-functional teams across R&D, Regulatory, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to commercialization. Develop and maintain project plans, schedules, and budgets, tracking milestones and dependencies. Report on project status, risks, and issues to stakeholders and leadership. Coordinate resources and prioritize tasks across departments for efficient project execution. Support regulatory submission activities, ensuring compliance with standards like FDA and ISO 13485. Facilitate project meetings, including updates, risk reviews, and issue resolution. Manage external vendors and partners involved in development and manufacturing. Contribute to process improvements in project management methodologies. Maintain project documentation and support governance processes. Requirements Qualifications: Bachelor’s degree in Life Sciences, Engineering, Business, or related field; advanced degrees preferred. 5-8 years of project management experience in biotech, diagnostics, or medical devices, especially in regulated environments. Understanding of regulatory pathways, quality systems (ISO 13485), and product commercialization for IVDs or medical devices. Proven ability to manage cross-functional teams and deliver projects on time and within budget. Experience in Life Science/IVD industry highly preferred. PMP certification or formal project management training strongly desired. Excellent organizational, leadership, and interpersonal skills. Ability to thrive in a dynamic, fast-paced environment with shifting priorities. Skills & Competencies: Experience supporting global product launches and managing distributed teams. Familiarity with project management software and tools. Exposure to Agile or Stage-Gate development methodologies. Strong problem-solving, decision-making, and critical thinking skills. Experience working with external partners and managing vendor relationships is a plus. Benefits: Comprehensive medical, dental, and vision insurance. 401(k) plan with company contributions. Flexible paid time off (PTO). Additional benefits. Equal Opportunity Statement:
We are an equal opportunity employer committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, marital status, or any other protected characteristic.
#J-18808-Ljbffr