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Mgr GCP Quality

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 7, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Responsible for supporting the Veeva-based Quality Management System (QMOD) through project leadership and providing technical expertise for Issue Management, Quality Auditing and other system implementations in the Global Development Quality domain. The Regeneron GCP Quality Manager will work cross-functionally with GCP Quality colleagues and Global Development Solutions to lead projects, oversee development and manage deployment of changes to the Quality Management System. They will provide input to help define strategy and governance in relation to the Quality Management System.

In this role, a typical day might include the following:

  • Defines opportunities/projects to improve the systems and processes supporting Global Development Quality
  • Develops tools, standards and techniques to improve the Quality Management System
  • Assesses new Veeva technology features for improvement opportunities
  • Leads/supports the delivery of QMOD configuration change controls
  • Leads/supports QMOD data quality enrichment and implementation of data standards
  • Is a Subject Matter Expert on QMOD/Veeva related projects
  • Collaborates with Global Development Quality colleagues, Global Development Solutions and other key stakeholders
  • Functions as a super-user and QMOD expert on all system-supported processes and data requirements 
  • Develops reports and metrics to support continuous improvement
  • Works independently and provides support to other team members

This role may be for you if:

  • Quality Management Computer System administration experience (Veeva Vault preferable)
  • GCP/GVP/GLP exposure
  • Quality Assurance/Compliance experience
  • Business Analysis and Project Management expertise
  • Dealing with complexity and ambiguity
  • Demonstrated skills in taking initiative and working with minimal supervision
  • Interacts with Senior Management/Leadership Teams

To be considered you should have a Bachelor’s degree/MS Preferred/7-9+ years experience. Excellent problem solving, written and verbal communication skills. Exhibits creativity and resourcefulness in the delivery of their work. Attention to detail and accuracy of work

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! 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!


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 parental 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.

#GDRAJobs

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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