Assoc Compliance Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 92,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking an individual to support Process Sciences by overseeing all aspects of cGMP compliance and quality records. The role emphasizes coordination across departments, training on technical writing, and maintaining key quality metrics.

The position values experience with change controls, CAPAs, and supplier notifications, with emphasis on consistent records and proactive compliance in a fast-paced biotech environment.

Qualifications

• Assoc: BS/BA in scientific discipline or related field with 0-2+ years industry experience; or equivalent combination of education and experience.
• Int: BS/BA in scientific discipline or related field with 2+ years industry experience; or equivalent combination of education and experience.
• Sr: BS/BA in scientific discipline or related field with 5+ years industry experience; or equivalent combination of education and experience.

Responsibilities

• Execute, monitor, and track progress of Process Sciences owned quality records, such as Change controls, supplier notifications and CAPAs.
• Be a SME for quality records and quality systems, ensuring consistency of records.
• Train and promote technical writing and quality awareness.
• Maintain and communicate appropriate metrics.
• Review department owned quality records for compliance and accuracy.
• Strong communicator to represent Process Sciences at daily & weekly cross functional meetings.
• Act as a liaison for coordination of changes between the Process Sciences department and other departments.
• Drive proactive compliance environment in the Process Sciences department through knowledge transfer and education of compliance related items.

Skills

Quality records

Quality systems

Technical writing

Metrics communication

Cross-functional collaboration

Education

Assoc/BS in scientific discipline

Int BS/BA in scientific discipline

Sr BS/BA with 5+ years

Job description

Summary

Supports the Process Sciences department by providing oversight for all aspects of cGMP compliance.

Essential Duties and Responsibilities

• Execute, monitor, and track progress of Process Sciences owned quality records, such as Change controls, supplier notifications and CAPAs.
• Be a SME for quality records and quality systems, ensuring consistency of records.
• Train and promote technical writing and quality awareness.
• Maintain and communicate appropriate metrics.
• Review department owned quality records for compliance and accuracy.
• Strong communicator to represent Process Sciences at daily & weekly cross functional meetings.
• Act as a liaison for coordination of changes between the Process Sciences department and other departments.
• Drive proactive compliance environment in the Process Sciences department through knowledge transfer and education of compliance related items.

Education and Experience

• Assoc: BS/BA in scientific discipline or related field with 0-2+ years industry experience; or equivalent combination of education and experience.
• Int: BS/BA in scientific discipline or related field with 2+ years industry experience; or equivalent combination of education and experience.
• Sr: BS/BA in scientific discipline or related field with 5+ years industry experience; or equivalent combination of education and experience.

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. 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $62,355.00 - $92,400.00

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.