Director, Medical Device Quality Assurance
Regeneron Pharmaceuticals · East Greenbush, NY, US
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About the Role
Regeneron is seeking a Director, Quality Assurance to lead the Medical Device Quality Assurance team. This role provides oversight of Combination Products development for biological therapeutics, collaborating with internal and external partners.
Responsibilities
- Providing Quality Assurance oversight of the Medical Device / Combination Products function.
- Collaborating across the organization to provide development support.
- Developing strategies and processes to strengthen the integration of Combination Product development into the Regeneron organization.
- Creating resource plans to ensure adequate quality assurance support of combination product development projects, and other projects across the organization.
- Leading all aspects of the professional development of the Medical Device Quality Assurance team, including managers and engineers.
- Driving the department for optimal performance, reducing errors and improving efficiencies.
- Setting goals for the department to align with corporate quality assurance goals.
- Collaborating with internal collaborators, external partners, and agencies.
Requirements
- BS/BA and 12+ years of experience in the medical device or combination product industry, or equivalent combination of education and experience.
- Understanding of applicable industry regulations, including 21CFR Part 4, 21 CFR Part 820, and ISO 13485.
- Demonstrated knowledge of combination product development requirements, specifically related to Design Controls.
- Current knowledge and/or experience with QA systems such as CAPA, deviations, investigations, change control, etc.
Location
- East Greenbush, New York, United States
Work Type
- On-site
Experience Level
- 12+ years
Education Level
- BS/BA
Salary/Compensations
- $175,700.00 - $292,700.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
Equal Opportunity
- 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.