Associate Director, QA Investigations

Company: Regeneron Pharmaceuticals, Inc.
Location: Rensselaer
Posted on: July 16, 2025

Job Description:

We are currently looking to fill an Associate Director, QA Investigations position. This position is responsible for providing oversight of the quality review, quality approval and management of deviation events, investigations and CAPA. Site Owner of the investigation and CAPA systems operations. In this role, a typical day might include the following: Leads a team with direct oversight of review and approval for deviations, laboratory investigations and corrective actions. May review, verify and approve system records. Collaborates across QA to provide succinct support to investigation teams to drive quality outcomes. Approves and reviews SOP revisions. Provides QA direction for cross-functional investigation hub and at points of critical issue within cross-functional teams. Involved in post-production management of events to facilitate closures to meet the required timelines. Identify leading practices and recommend improvements to continuously improve compliance profile. Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for operations. Serves as a subject matter authority to present topics to management and during inspections. Supervises quality system metrics including deviations, corrective actions and controlled document workflows. Drafts and implements long-term planning for the process, staff and budget. Performs personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.). Makes decisions and develops and implements policies. Ensures that policies and procedures are effectively coordinated and align with regulatory requirements and current good manufacturing practices (cGMPs). This role might be for you if you: Have experience leading a large team of quality minded individuals Continuously seek to improve processes for improved performance Have detailed knowledge of cGMPs Excel in a quality driven organization Have an understanding of biologics manufacturing operations To be considered for this role you must hold a Bachelors degree in Life Sciences or related field and the following amount of relevant cGMP manufacturing experience for each level: Associate Director 10 years, including 5 years of supervisory experience Director 12 years, including 6 years of supervisory experience Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement. 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) $145,600.00 - $282,600.00

Keywords: Regeneron Pharmaceuticals, Inc., Westfield , Associate Director, QA Investigations, Science, Research & Development , Rensselaer, Massachusetts