Regeneron Pharmaceuticals, Inc

Quality Compliance Specialist (Change Controls)

Regeneron Pharmaceuticals, Inc$62K — $110K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in life sciences or related field; proven experience may substitute education requirement
  • 0-2+ years for Associate Quality Compliance Specialist
  • 2+ years for Quality Compliance Specialist
  • Strong knowledge of biotech/pharmaceutical quality systems including cGMP and FDA regulations
  • Digital proficiency in MS Office; experience with Veeva/QMS is a plus

Responsibilities

  • Review and approve change control documentation for regulatory compliance
  • Facilitate cross-functional meetings for change control guidance
  • Build relationships with end users on change control processes
  • Partner with QA and end users to improve change control systems
  • Interpret compliance requirements for documentation
  • Support audits as a subject matter expert on change control
  • Analyze technical procedures and regulations for decision-making

Benefits

  • Student loan paydown program and tuition reimbursement
  • Family care benefits
  • Relocation assistance
  • Inclusion, culture, and well-being programs for physical and mental health
Full Job Description

This position will focus on internal change controls. The Quality Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities.

When & where:

  • Location: Rensselaer, New York, United States
  • Work model: Monday-Friday, 8am-4:30pm

What you'll do:

  • Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements
  • Facilitate cross-functional meetings, offering guidance and consultation to change control owners throughout the process
  • Build strong relationships with end users, serving as a go-to resource on standard change control processes
  • Partner with quality assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures
  • Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation
  • Support regulatory and customer audits as a subject matter expert on change control
  • Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards
  • Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment
  • Leverage strong digital proficiency in MS Word, Excel, and PowerPoint; experience with Veeva/QMS is a plus

Let’s find out if we’re a fit:

  • Requires B.S in life sciences or related field; may substitute proven experience for education requirement
    • Associate Quality Compliance Specialist: 0-2+ years of experience
    • Quality Compliance Specialist: 2+ years of experience
    • Level will be determined based on experience

Thrive today. Grow tomorrow.

  • Student loan paydown program & tuition reimbursement
  • Family care benefits
  • Relocation assistance
  • Inclusion, culture and well-being programs (including physical & mental health)

Salary Range (annually)

$62,355.00 - $110,000.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

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