Sr. Manager, Medical Device Quality Assurance

Regeneron Pharmaceuticals • Valley, AL

2d • Onsite

About The Position

Regeneron is seeking a Senior Manager, Medical Device Quality Assurance (QA) to join the Medical Device QA team. This leadership role will provide QA oversight for Combination Products Sustaining Engineering and Compliance. The position will lead a team of engineers and quality specialists. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Requirements

• B.S in Engineering and 8+ years of experience; including combination product or medical device experience; or equivalent combination of education & experience
• Previous supervisory/ people leadership experience
• Knowledge of the combination device development and lifecycle process

Responsibilities

• Manage, mentor, and develop quality engineering and compliance teams
• Standardize, streamline, and improve processes across sustaining and compliance
• Implement digital, data-driven tools for accurate, consistent, and timely reporting
• Lead teams through complex, ambiguous challenges in a pharmaceutical/medical device environment
• Support sustaining engineering programs through risk assessment, design change management, and maintenance of the Design History File and Risk Management File
• Advice and actively participate in Design Reviews associated with combination products
• Provide QA and technical support to quality engineers and project teams during ongoing maintenance of the combination product
• Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities
• Act as Management Representative for the combination products QMS; own policies and procedures
• Support regulatory inspections and partner audits for combination products
• Keep the QMS current and inspection-ready via monitoring, gap assessments, and updates

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager