Director, Medical Device Quality Assurance

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 176,000 - 293,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension/retirement benefits

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. (USA) is seeking a Director of Quality Assurance to join the QA Medical Device team in East Greenbush, NY.

The role focuses on oversight of Medical Device/Combination Products, development support, and strategic integration of design controls across programs. The ideal candidate will have a BS/BA with 12+ years in the medical device space, in-depth knowledge of 21 CFR Parts and ISO 13485, and strong leadership to drive performance and collaboration with partners

Qualifications

• BS/BA in a related field with 12+ years in medical device or combination product industry.
• Proven knowledge of design controls, CAPA, deviations, investigations, and change control.

Responsibilities

• Provide QA oversight of Medical Device/Combination Products.
• Collaborate across the organization to provide development support.
• Develop strategies to integrate combination product development into Regeneron.
• Create resource plans to ensure QA support for projects.
• Lead the Medical Device QA team, including managers and engineers.
• Drive department performance, reduce errors, and improve efficiencies.
• Set department goals aligned with QA objectives.
• Collaborate with internal and external partners and agencies.

Skills

12+ years medical device experience

Regulatory knowledge (21 CFR Part 4, 5

Education

BS/BA degree

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Director, Quality Assurance position to join our QA Medical Device team.

Location & Schedule

Location: East Greenbush, New York, United States

Work schedule: Monday-Friday, 8am-4:30pm

Responsibilities

• Providing Quality Assurance oversight of the Medical Device / Combination Products function.
• Collaborates across the organization to provide development support.
• Develops strategies and processes to strengthen the integration of Combination Product development into the Regeneron organization.
• Creates resource plans to ensure adequate quality assurance support of combination product development projects, and other projects across the organization.
• Leads all aspects of the professional development of the Medical Device Quality Assurance team, including managers and engineers.
• Responsible for driving the department for optimal performance, reducing errors and improving efficiencies.
• Sets goals for the department to align with corporate quality assurance goals.
• Collaborates 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.

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.

In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• 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

For other locations, additional information will be provided during the recruitment process.

Salary Range

Salary Range (annually) $175,700.00 - $292,700.00

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.