Assoc Compliance Specialist

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

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality Records Specialist within the Process Sciences department in the United States.

You will oversee cGMP quality records, drive change controls, CAPAs, and supplier notifications, acting as a Subject Matter Expert for quality systems and record integrity. You will train staff in technical writing and quality awareness, maintain key metrics, and coordinate changes across departments to ensure compliant documentation and proactive regulatory

Qualifications

• BS/BA in scientific discipline or related field with 0-2+ years industry experience for Associate level.
• BS/BA in scientific discipline or related field with 2+ years industry experience for Intermediate level.
• BS/BA in scientific discipline or related field with 5+ years industry experience for Senior level.

Responsibilities

• Execute, monitor, and track progress of Process Sciences quality records (Change controls, supplier notifications, CAPAs).
• Serve as SME for quality records and systems, ensuring record consistency.
• Train and promote technical writing and quality awareness across the team.

Skills

Quality systems

CAPA management

Change controls

Technical writing

Cross-functional communication

Education

Assoc: BS/BA in scientific discipline

Int: BS/BA in scientific discipline

Sr: BS/BA in scientific discipline

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.

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