Director, Medical Device Quality Assurance
About The Position
Regeneron is seeking a Director of Quality Assurance to lead its Medical Device Quality Assurance team. The role provides oversight of Combination Products development for biological therapeutics developed in-house and in collaboration with partners and contract manufacturing organizations (CMOs). It is based in East Greenbush, New York, and follows a Monday–Friday schedule from 8:00 a.m. to 4:30 p.m. The Director collaborates across the organization to support development, strengthen the integration of Combination Product development into Regeneron, and ensure adequate Quality Assurance support through resource planning. The role leads the professional development of the Medical Device Quality Assurance team, including managers and engineers, and drives department performance, error reduction, and efficiency. It also establishes departmental goals aligned with corporate Quality Assurance goals and collaborates with internal stakeholders, external partners, and agencies.
Requirements
- BS/BA and 12+ years of experience in the medical device or combination product industry, or an equivalent combination of education and experience.
- Understanding of applicable industry regulations, including 21 CFR Part 4, 21 CFR Part 820, and ISO 13485.
- Demonstrated knowledge of Combination Product development requirements, specifically Design Controls.
- Current knowledge and/or experience with Quality Assurance systems such as CAPA, deviations, investigations, and change control.
Responsibilities
- Provide Quality Assurance oversight of the Medical Device / Combination Products function.
- Collaborate across the organization to provide development support.
- Develop strategies and processes to strengthen the integration of Combination Product development into the organization.
- Create resource plans to ensure adequate Quality Assurance support for Combination Product development and other organizational projects.
- Lead the professional development of the Medical Device Quality Assurance team, including managers and engineers.
- Drive department performance, reduce errors, and improve efficiencies.
- Set departmental goals aligned with corporate Quality Assurance goals.
- Collaborate with internal stakeholders, external partners, and agencies.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Director
