Quality Assurance Compliance Specialist, Change Control

Regeneron Pharmaceuticals, Inc (USA); United States; Presencial; USD 67.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses or incentive plans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, 9

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a Quality Assurance Compliance Specialist, Change Control to ensure cGMP compliance and effective change control processes.

You will review change control documents, lead cross‑functional discussions and advise on best practices while supporting audits and continuous improvement initiatives. The role emphasizes independent work, strong attention to detail, and collaboration with QA and end users to uphold global regulatory standards.

Formación

• Bachelor's in scientific or engineering field with relevant experience in quality/regulatory
• Experience with cGMP, FDA regulations and global regulatory expectations
• Proven ability to work independently with attention to detail and scientific judgment
• Strong communication skills and ability to influence across levels
• Proficient in MS Word, Excel and PowerPoint; digital literacy required

Responsabilidades

• Review, assess, edit, and approve change control documentation per quality, regulatory and SOP requirements
• Facilitate cross-functional meetings and guide change proposal owners
• Advise end users on best practices in Change Control
• Partner with QA team and system users to improve the Change Control system
• Identify, develop, and implement continuous improvements to the Change Control process
• Interpret regulatory requirements for inclusion in procedures and documentation
• Support regulatory and customer audits

Conocimientos

cGMP knowledge

FDA regulations

ICH guidelines

Attention to detail

Cross-functional

MS Office

Change control

Educación

Bachelor's in science/engineering

Herramientas

QUMAS

Descripción del empleo

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility. In this role, the Quality Assurance Compliance Specialist ensures quality and compliance to cGMP’s, internal, external, and international requirements with respect to changing control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Rensselaer, New York, United States

Work model: Monday-Friday, 8:00 AM - 5:00 PM

Discover your role:

• Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitating cross functional meetings and providing guidance and consultation to change proposal owners
• Developing relationships with end users and providing advice on best practices in Change Control
• Partnering with other members of the Quality Assurance team and/or end users of the system to
• Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures
• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
• Supporting regulatory and customer audits.

This role might be for you if:

• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.
• Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
• Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment.
• Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan.
• Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
• Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required.
• Experience with Process Compliance/QUMAS heavily preferred.

This role requires:

• Bachelors in a scientific or engineering discipline or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.
• Associate Specialist – 0‑2+ years
• Specialist – 2‑5+ years
• Senior Specialist – 5+ years
• Level is determined based on qualifications relevant to the role.

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) $67,400.00 - $110,000.00

We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.