Manager QA Validation (Oversight) at Regeneron Pharmaceuticals, Inc.

We are currently looking to add a Manager QA Validation to our team. This position leads a team responsible for the qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regenerons Rensselaer facility. You will participate and defend validation data in FDA and other regulatory inspections.

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

• Designing and developing policies related to validation and ensuring that they are effectively administered and align with regulatory requirements.

• Being 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

  • Validation Master Plans

• Managing Validation team by developing validation work plans, establishing objectives, and assigning tasks.

• Developing and managing validation budget, contracts, and schedules.

• Presenting/defending validation data to FDA and other regulatory agencies.

• Maintaining validation document and software control system while ensuring that validation status is maintained for equipment and software use in commercial and clinical manufacturing.

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

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

• Have validation experience in a GMP environment

• Build and maintain strong working relationships across the business and with external partners, while providing exceptional customer service

• Have a continuous improvement mentality to identify and implement improvement opportunities

• Have supervisory/leadership experience

To be considered for this role you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences with a minimum of 7 years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)