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Manager QA Validation

Employer
Regeneron Pharmaceuticals, Inc.
Location
East Greenbush, New York
Start date
Mar 31, 2024

View more

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

Job Details

The QA Validation department at Regeneron is adding to their team! The Manager for QA Validation within our Fill Finish area would lead the department that is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regenerons Rensselaer facility. This group also participates and defends validation data in FDA and other regulatory inspections.

Shifts Available: 2nd Shift, Monday-Friday, 2pm-10:30pm

The day to day of a Manager for QA Validation could include, but are not limited to, the following:

  • Designs and develops policies related to validation and ensures that they are effectively administered and comply with regulatory requirements.

  • Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions: Failure investigations, Change controls and associated Test Plan documentation, SOPs, Validation protocols and summary reports, and Validation Master Plans

  • Interviews, hires, and trains incoming personnel.

  • Manages Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks.

  • Develops and manages validation budget, contracts, and schedules

  • Maintains validation document and software control system.

  • Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.

  • Organizes QA Validation resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.

  • Plays a proactive role in developing and applying new approaches and processes to validation strategies.

  • Regularly interacts with senior managers and executives to create a broad-based validation program.

  • Applies complete functional knowledge and awareness of company goals and objectives.

  • Counsels employees about work performance; conducts hiring and discharge interviews.


To be considered for this role, you must possess a Bachelors degree in Engineering, Chemistry, or Life Sciences with the minimum amount of years of experience for each level:
  • Associate Manager: 6+ years

  • Manager: 7+ years

  • Sr. Manager: 8+ years

  • Experience leading, supervising, or managing others required

  • May substitute proven experience for education requirement

#REGNQA

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$89,100.00 - $199,000.00

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
US

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