Within this role you will be responsible to manage the commercial manufacturing compliance requirements and the compliance team in relation to completion of quality instances for the Manufacturing departments.
As a Manager in the Compliance team, a typical day might include, but is not limited to the following:
Managing a team responsible for the delivery of the manufacturing compliance records in a cGMP regulatory environment
Overseeing the scheduling of team duties and tasks
Ensuring timely management of quality instance closure
Reviewing , editing and approving compliance records in accordance with cGMP standards
Coordinating and ensuring quality system instances meet required timelines
Recommending corrective actions based on investigational findings working cross functionally and cross site to reach agreement
Tracking quality system metrics including deviations, corrective actions and change controls
Ensuring audit readiness and coordinates where required
Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations
Interfacing with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control
Representing Manufacturing at meetings
This role might be for you if:
You have demonstrated experience leading and motivating a team
You enjoy problem solving, using your verbal and written communication skills to achieve the desired outcome
You can adhere to the letter and spirit of policies and regulations
To be considered for this opportunity you must have a BS/BA in Life Sciences or related field with 7+ years of relevant cGMP manufacturing experience and some previous supervisory/leadership experience. Will substitute relevant experience in lieu of educational requirement.
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.