Director QA Validation

We are currently looking to fill a Director, QA Validation (Drug Product) position. This position leads department responsible for Drug Product Qualification/Validation including but not limited to qualification of equipment, utilities, automation, shipping, and validation of cleaning, sterilization, decontamination, and aseptic process simulation. This position will serve as validation site lead for the fill/finish site and will participate in regulatory inspections/interactions.

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

• Designs and develops policies related to validation and ensures that they are effectively coordinated and align with regulatory requirements

• Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions:

  • change controls

  • SOPs

  • Policies

  • validation protocols and summary reports

  • validation master plans

  • investigation

• Interviews, hires, orients, and trains incoming team members

• Leads Validation Department team by developing validation work plans, establishing objectives, and assigning tasks

• Develops validation budget, contracts, and schedules

• Measure and organize work as a means to influence collaborators and provide proactive solutions

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

• Ensures that validation status is maintained for equipment and systems used in commercial and clinical manufacturing

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

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

• Regularly interacts with cross-functional senior managers and executives to build 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 you:

• Have strong leadership and project management skills

• Are experienced in biopharma manufacturing validation principals

• Thrive in a quality focused environment

• Are able to mentor and encourage others

• Possess a positive, proactive approach to drive projects/tasks to completion

To be considered for this role you must hold a BA/BS degree in Engineering, Chemistry, or Life Sciences preferred with the following amount of relevant experience in pharmaceutical or biopharmaceutical facilities and manufacturing for each level:

• Associate Director 10+ years

• Director 12+ years

• Sr Director - 15+ years

At least 5 + years experience specifically in a validation/quality assurance function and managerial experience required. Equivalent combination of education and experience may be considered. Level to be determined based on qualifications relevant to the role.

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)