Job Title: Diagnostic Quality Lead
We are seeking a skilled professional to join our team as a Diagnostic Quality Lead. This role is responsible for ensuring adherence to global IVD regulations and quality requirements.
Key Responsibilities:
* Develop, implement, and maintain a robust process for the assessment of in vitro diagnostic (IVD) products used within clinical trials.
* Drive cross-functional excellence across diagnostic operations, quality & compliance execution, and clinical diagnostic delivery.
* 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 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 understanding of design control, risk management, assay validation, and design history file creation.
Required Skills and Qualifications:
* Minimum Bachelor's Degree (Master's level degree preferred)
* 8 years of relevant experience
* Expertise in IVD applications in the clinical trial setting
* Diagnostics Operations Function:
o 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)
* Strong understanding of laboratory practices, validation procedures, and regulatory requirements
* Proficient in business technology tools and understanding data (e.g., Microsoft Teams, Excel, Power Point, etc.)
* Drug development experience preferred
* Design History File audit expertise, not required but of interest
Benefits:
* Comprehensive benefits package, which often includes health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Others:
* We have an inclusive and diverse culture that provides opportunities for growth and development.
* Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.