Regeneron is hiring a Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead to drive excellence in diagnostic operations and quality compliance for our clinical trials. You will develop, implement, and maintain a robust process for assessing in vitro diagnostic (IVD) products, ensuring adherence to global IVD regulations to support our drug development portfolio.
What You'll Do
- Lead cross-functional collaboration to design IVD assessment processes, tools, framework, and governance.
- Own and manage the IVD assessment process, including project maintenance, updates, technology, and governance.
- Engage with internal and external collaborators for timely deliverables supporting IVDs for clinical trials.
- Author and maintain structured materials like SOPs, templates, and guidance documents.
- Oversee and facilitate activities of external partners and vendors to ensure high quality.
- Lead or contribute to continuous improvement initiatives within IVD quality and execution.
- Provide diagnostic and laboratory quality best practices on design control, risk assessments, and CAPAs.
- Contribute to IVD projects with vendor laboratories to align development with the clinical program.
- Oversee and manage device monitoring activities.
- Manage stakeholder relationships with external diagnostic partners and laboratories.
- Serve as a subject matter expert during diagnostic and clinical vendor lab audits.
- Evaluate compliance with internal procedures, industry, and regulatory requirements.
- Partner with QA and cross-functional teams to assess laboratory capabilities and data integrity.
- Participate in audit planning, execution, and follow-up activities.
- Review and contribute to audit reports, CAPA plans, and remediation follow-ups.
- Support internal and external audit readiness.
- Work closely with vendors on the development of IVDR-compliant diagnostic assays.
- Collaborate with internal stakeholders and laboratory vendors to ensure globally compliant product design.
- Communicate effectively with stakeholders and escalate risks.
- Support quality activities for new product development, including design control and risk management.
What We're Looking For
- Minimum Bachelor's Degree with 8 years of relevant experience.
- Expertise in IVD applications in the clinical trial setting.
- Diagnostic and laboratory quality, regulatory, and compliance experience.
- Solid understanding of global regulatory requirements (e.g., EU IVDR, 21 CFR 820, ISO 13485, ISO 14971, CAP/CLIA, ICH, GDP).
- Strong understanding of laboratory practices, validation procedures, and regulatory requirements.
- Proficient in business technology tools (e.g., Microsoft Teams, Excel, PowerPoint).
- Ability to travel up to 25%.
- Desire to have an impact on patient lives.
- Ability to work in a rapid response environment.
- Ability to lead by influence in a cross-functional matrix team.
- Experience working with cross-functional clinical study teams.
- Strong communication and presentation skills.
- Highly organized with a strategic mindset.
Nice to Have
- Master’s level degree.
- Drug development experience.
- Design History File audit expertise.
Technical Stack
- Microsoft Teams
- Excel
- PowerPoint
Team & Environment
You will work within a cross-functional matrix team, collaborating with scientists, clinicians, and quality professionals.
Benefits & Compensation
- Compensation: $148,300.00 - $241,900.00
- Health and wellness programs
- Fitness centers
- Equity awards
- Annual bonuses
- Paid time off
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.
