Manager QA Validation (Drug Product / Fill Finish)

The QA Validation team is hiring a Manager to lead the department responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's facilities.

In this role, a typical day may include:

• 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, orient, 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

• Presents/defends validation data to FDA and other regulatory agencies

• 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 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

This role might be for you if:

• Excel in a quality driven organization

• Have drug product component supplier quality experience

• Are organized and have an attention to detail

• Can prioritize multiple assignments and changing priorities

• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor's degree in a related field and the minimum amounts of experience for each level:

• Associate Manager: 6+ years

• Manager: 7+ years

• Sr. Manager: 8+ years

#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)