Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead

We are seeking a Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead to join our Precision Medicine Team!

In this role, a typical day might include:

The candidate will drive cross-functional excellence across diagnostic operations, quality & compliance execution, and clinical diagnostic delivery.  This individual will develop, implement, and maintain a robust process for the assessment of in vitro diagnostic (IVD) products used within our clinical trials.  This role is responsible for ensuring adherence to global IVD regulations and quality requirements to help manage delivery of diagnostics to support our drug development portfolio.
 

This role might be for you if you can/have:

Diagnostics Operations Function:

• Lead cross-functional collaboration to design IVD assessment processes and tools, framework, governance for consistent evaluations, risk identifications, and alignment with global regulatory expectations (e.g., EU IVDR, 21 CFR 820, ISO 13485, ISO 14971).
• Own and manage the IVD assessment process, tools, and templates – including project maintenance, updates, technology and governance.
• Engage with relevant internal and external collaborators for accurate and timely deliverables supporting IVDs required for Regeneron clinical trials.
• Author and maintain structured materials, such as SOPs, templates and guidance documents, to proceduralize the new process.

Diagnostics Quality Project Execution:

• Oversee and facilitate activities of external partners and vendors (diagnostic partners, testing laboratories and central laboratories) to ensure high quality.
• Lead or contribute to continuous improvement initiatives within IVD quality and execution.
• Provide diagnostic and laboratory quality best practices & feedback to internal and external stakeholders on design control, risk assessments, quality events and CAPAs.
• Contribute to IVD projects with vendor laboratories ensuring development aligns with the clinical program.
• Oversee and manage device monitoring activities as part of Regeneron’s diagnostic delivery.
• Stakeholder management of external collaborations by working closely with external diagnostic partners, central laboratories and specialty testing labs.

Audit Support

• Serve as a subject matter expert during diagnostic & clinical vendor lab audits.
• Evaluate compliance with internal procedures, industry and regulatory requirements.
• Partner with QA and cross functional teams to assess laboratory capabilities, processes, and data integrity.
• Participate in audit planning, execution, and follow-up activities, including documentation review and on-site inspection.
• Review and contribute to audit reports, CAPA plans and remediation follow-ups.
• Support internal/external audit readiness

Clinical Diagnostic Delivery:

• Work closely with vendors in overseeing the development of an IVDR (or other global IVD regulations) compliant diagnostic assay to be used in Regeneron clinical studies and/or performance studies. 
• Collaborate with internal key stakeholders and laboratory vendor to ensure product design and development is globally compliant and ready to implement with the clinical study timelines.
• Communicate effectively with stakeholders and escalate risks.
• Support quality activities for new product development including a strong understating of design control, risk management, assay validation and design history file creation. 

To be considered for this opportunity, you must have the following:

• Minimum Bachelor's Degree (Master’s level degree preferred) with 8 years of relevant experience.
• Expertise in IVD applications in the clinical trial setting
• Diagnostic and laboratory quality, regulatory & compliance experience
• Solid understanding of global regulatory requirements (e.g. EU IVDR, 21 CFR 820, ISO 13485, ISO 14971, CAP/CLIA, ICH, GDP, etc.)
• Strong understanding of laboratory practices, validation procedures and regulatory requirements.
• Proficient in business technology tools and understanding data (e.g. Microsoft Teams, Excel, PowerPoint, etc.)
• Drug development experience preferred
• Design History File audit expertise, not required but of interest
• Must be able to travel up to 25%
• Want to have an impact on patient lives
• Enjoy working in a “rapid response” environment
• Can lead by influence in a cross-functional matrix team
• Want to work with hard-working scientist and clinicians
• Experience working with cross-functional clinical study teams
• Strong communication and presentation skil