Regeneron Pharmaceuticals, Inc

Director, Quality Technical Operations

Regeneron Pharmaceuticals, Inc$172K — $338K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences or related field required.
  • 12+ years of pharmaceutical manufacturing experience for Director level.
  • 15+ years of experience for Sr. Director level.
  • Proven leadership in cGMP environments.
  • Hands-on experience in QA systems and metrics.

Responsibilities

  • Define and implement quality standards for manufacturing operations.
  • Provide oversight for validation activities and regulatory compliance.
  • Oversee QA tasks related to electronic manufacturing records and tech transfer.
  • Compile and present quality metrics to senior leadership.
  • Plan QA resources effectively to meet goals and priorities.
  • Coordinate with management to optimize execution of activities.
  • Prepare for and manage regulatory and customer audits.

Benefits

  • Health and wellness programs (medical, dental, vision, life, and disability insurance).
  • Fitness center access.
  • 401(k) company matching.
  • Equity awards and annual bonuses.
  • Paid time off and various paid leaves.
Full Job Description
Director, Quality Technical Operations

You will lead a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. You'll define and implement cGMP best practices, set quality standards and metrics, and ensure clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements.

When & where:
  • Location: Rensselaer, NY
  • Work model: Monday-Friday, 8am-4:30pm


Discover your role:
  • Define and implement quality standards, systems, and metrics across clinical and commercial manufacturing operations.
  • Provide quality oversight to activities related to validation and ensure that they are effectively administered and comply with regulatory requirements.
  • Oversee QA tasks related to electronic manufacturing record management and tech transfer.
  • Compile, organize, and present quality metrics and trends to senior leadership.
  • Plan and allocate QA resources to meet program goals, timelines, and priorities.
  • Coordinate prioritization of activities with area management to optimize execution.
  • Prepare for regulatory and customer audits; ensure observations are addressed effectively and on schedule.
  • Maintain safety and operational standards and approve documents related to QA functions.


This role requires:
  • Bachelor's degree in Life Sciences, Engineering, or related field, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
    • Director - 12+ years
    • Senior Director - 15+ years
    • Level will be determined based on experience
  • Proven leadership in cGMP environments with hands-on experience in QA systems and metrics
  • A track record of successful audit readiness, execution, and response management
  • Strong collaboration, communication, and stakeholder engagement skills
  • An understanding of bulk API biologics manufacturing operations


#REGNQA

Salary Range (annually)
$172,200.00 - $338,400.00

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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