Location: Rensselaer,NY, USA
We are currently looking to fill an Associate Director/Director Investigations (Quality Control) position. This position is responsible for providing direction and oversight to the review, approval and management of investigations and corrective and preventive actions.
In this role, a typical day might include the following:
* Leads a team with direct oversight of review and approval for GMP Documents
* May review, verify and approve system records
* Collaborates cross functionally to provide succinct support to teams to strive to quality outcomes
* May approve and review Policy/SOP revisions
* Provides direction for cross-functional teams. Serves as an escalation point as well as determination when additional escalation is required
* Identify leading practices and recommend improvements to continuously improve compliance profile
* Serves as a subject matter authority (SME) to present topics to management and during inspections
* Supervises relevant quality system metrics including deviations and corrective actions. Uses metrics to identify and pursue initiatives
* Drafts and implements long-term planning for the process and staff
* 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 administered and align with regulatory requirements and current good manufacturing practices (cGMPs)
* Participates on internal committees/teams, as required
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 Bachelor's degree in Life Sciences or related field and the following amount of relevant cGMP manufacturing experience for each level:
* Associate Director - 10+ years
* Director - 12+ years
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)
$142,700.00 - $277,100.00