This job has expired

You will need to login before you can apply for a job.

Associate Project Manager Quality Assurance (Batch Management)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Aug 8, 2022

View more

You need to sign in or create an account to save a job.

Job Details

We are currently looking to fill an Associate Project Manager, Quality Assurance position. The Associate Project Manager provides quality oversight of manufacturing and/or validation activities at Contract Manufacturing Organizations (CMOs) and partners to ensure both parties are aligned on deliverables. Accomplishment is made through planning and evaluation of project activities.

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

  • Primary interface with External Manufacturing Project Managers for all quality related issues at CMOs and partners

  • Interacting with senior internal personnel and external partners on significant matters often requiring coordination across facility locations

  • Ensuring alignment of processes, procedures, and methods across multiple organizations (internal and external)

  • Maintaining compliance with Regeneron and global Regulatory standards and helping to establish standards where needs have been identified

  • Keeps abreast of changes in regulatory requirements and guidance as it pertains to drug product manufacturing. Through partnering with internal and externals drug product teams, share this information to increase the collective understanding and implication of these changes.

  • Assessing process/system effectiveness and efficiency

  • Developing and providing tools to enable system understanding across multiple organizations

  • Preparing and completing action plans; implementing productivity, quality, and customer-service standards

  • Implementing change when necessary within the guidelines of GMP manufacturing operations.

  • Authoring and /or revising SOPs

  • Assisting as needed in audits and inspections

This role may be for you if you:

  • Have comprehension of quality and cGMP principles, Quality Management Systems, and relevant Global regulatory guidelines

  • Have experience with Batch Record Review and disposition processes

  • Possess excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences

  • Have excellent time and project management skills with the ability to manage many diverse issues simultaneously

  • Are skilled in peer relationships, drive for results, dealing with ambiguity, learning on the fly, and individual courage

  • Excel in influencing, negotiating, problem-solving, analytical thinking, decision- making, collaborating, and organizing

To be considered for this role you must hold a Bachelor’s degree and a minimum of 8 years of industry/relevant experience.

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 maternity 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.

#REGNQA

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

FacebookTwitterInstagramYouTube Logo

Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert