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Manager/Sr Manager Technical Operation Quality Compliance

Job Description

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Summary: Responsible for the management and leadership of the Technical Operations Quality & Compliance function, providing quality and compliance oversight and support to the Facilities, Engineering and Automation departments under the Site Technical Operations group.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Responsible for the management and leadership of the Technical Operations Quality & Compliance team, including supervision, coaching, mentoring to direct reports and other compliance specialists as required

  • Working in conjunction with leaders across other Technical Operations functions in all aspect of quality and compliance, in particular the management of quality instances through the quality systems including complex technical investigations, the oversight and performance monitoring of all quality and compliance related critical metrics, the development and delivery of an audit readiness program including the delivery of appropriate technical and regulatory focused training.

  • Ensures team compliance with all departmental policies and procedures.

  • Interface across the business with Quality Assurance, Manufacturing and other functional areas as part of cross functional investigations, responsible for critical decision making and setting out future in order to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.

  • Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for Technical Operations commercial operations.

  • Continually reassess Facility, Engineering & Automation systems, procedures and processes for adherence to cGMP, Data Integrity regulatory requirements and industry best practices, implement changes/improvements as needed.

  • Represent the Facilities department on various topics during regulatory inspections, and coordinate responses to inspection observations as applicable.

  • Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.

Education and Experience:

  • Requires BS/BA in Life Sciences (or other technical/science field)

  • Manager requires 7 years in Quality Systems/Quality Compliance/Quality Operations role

  • Sr Manager 9 years in Quality Systems/Quality Compliance/Quality Operations role

#IREADV #JOBSIEST #LI-Onsite


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.