Regeneron Pharmaceuticals, Inc

Senior Manager GCP Quality

Regeneron Pharmaceuticals, Inc$134K — $219K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree and eight years’ relevant healthcare or pharmaceutical industry experience
  • Experience in quality, compliance, clinical development, GCP, or GPVP
  • Advanced knowledge of risk-based quality management and compliance
  • Experience handling complex issues and regulatory inspections
  • Subject matter expert with training and staff management experience
  • Skills in process improvement, project management, and time management
  • Proficient in Microsoft Office Suite and strong communication skills

Responsibilities

  • Lead risk-based quality management across clinical trials
  • Drive Quality Risk Assessment and Control Tracker activities under ICH E6 R3
  • Manage quality issues, audit responses, and trend analysis
  • Partner with study leads and contract research organizations on site risks
  • Escalate significant quality events to Executive Quality Leadership
  • Support inspection readiness and follow-up actions across functions
  • Oversee team administration and performance discussions

Benefits

  • Opportunities for hybrid work arrangement
  • Contribute to a fast-growing, science-driven organization
  • Engagement in meaningful work impacting patient outcomes
  • Professional development and growth in a supportive environment
  • Involvement in a collaborative team atmosphere
Full Job Description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Multiple locations are being considered for this role (Hybrid)

Discover your role:

  • Lead risk-based quality management across assigned clinical trials

  • Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3

  • Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis

  • Partner with study leads, monitoring teams, and contract research organisations on site risks

  • Escalate significant quality events and trends to Executive Quality Leadership

  • Support inspection readiness, responses, and follow-up actions across relevant functions

  • Manage onboarding, development goals, coaching, performance discussions, and team administration

  • You champion quality, integrity, continuous learning, and trusted partnerships

This role requires:

  • Bachelor’s degree and eight years’ relevant healthcare or pharmaceutical industry experience

  • Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience

  • Advanced risk-based quality management, risk assessment, and compliance knowledge

  • Experience managing complex issues, regulatory inspections, and inspection readiness

  • Subject matter expert, process owner, training, presentation, and staff management experience

  • Process improvement, project management, prioritisation, and time management skills

  • Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills

  • Strong communication, collaboration

Salary Range (annually)

$134,400.00 - $219,200.00

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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