Regeneron Pharmaceuticals, Inc

Senior Manager, Global Development Quality Assurance (GCP)

Regeneron Pharmaceuticals, Inc • $134K — $219K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
8 - 10 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree required, Master's preferred, with 8+ years of relevant industry experience
  • Deep knowledge of FDA and EU regulations and ICH guidance documents
  • 5+ years of direct people management and GCP audit experience
  • Excellent communication skills for all organizational levels
  • Experience with FDA regulatory inspections of investigator sites, sponsors, or CROs

Responsibilities

  • Manage and develop direct reports through monthly meetings and performance assessments
  • Conduct training and ensure proper resourcing for staff development
  • Schedule and perform audits in support of GxP compliance
  • Conduct internal and external audits on a global scale
  • Provide compliance input in cross-functional meetings
  • Identify internal quality/compliance issues and promote process improvements
  • Provide education and/or training to GDQA and other relevant departments

Benefits

  • Remote position based in the United States with required travel of 20-30%
  • Opportunity to contribute to a science-driven organization
  • Potential for significant professional development and growth in a key leadership role
  • Engagement in impactful quality assurance activities that influence drug development
Full Job Description
The Regeneron Senior Manager, Global Development Quality Assurance, is a key position in the supervising, guiding and leading for one of the Good Clinical Practice (GCP) audit programs. Responsibilities include managing direct reports while supporting the development and execution of departmental mission, vision and goals. As part of the role of people manager, you will be responsible for staff development & training and resourcing direct reports. You will create strategic partnerships and implement risk-based quality auditing activities.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:
This is a United States based remote position. This role may require 20 - 30% travel (both domestic and international).

Discover your role:
• Manage, hire and develop direct reports by meeting with direct reports at least monthly and conducting performance assessments.
• Responsible for the training, resourcing, and individual staff development.
• Schedule, prepare, conduct, report, and follow-up on audits in support of routine and directed GxP audits as needed and in accordance with our standard operating procedures and quality policies.
• Audits include internal audits and external audits conducted globally.
• Represent the department by providing audit and compliance input in cross functional meetings
• Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices. .
• Interpret and may assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations.
• Provides education and/or training to GDQA and other relevant Global Development departments.
• May participate in regulatory inspections by acting as part of the control and/or inspection room team

This role requires:

As Bachelor's degree (Master's degree preferred) with 8+ years of relevant industry experience Deep knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and/or post-authorization safety monitoring is required. 5+ years of both direct people management and GCP audit experience preferred Excellent communication and people management skills and ability to work with people in all levels of the organization and externally. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Strong leadership with demonstrated ability to collaborate with both direct reports and senior leaders
• Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues.
• Strong track record of project management, partner management, collaboration skills and negotiation of complex situations

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
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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