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Manager, Quality Compliance

Job Description

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We are currently looking to fill a Manager, Quality Compliance position. This position will be responsible for providing oversight of the quality review, quality approval and management of IOPS product quality complaint investigations and associated CAPA. This position will act as an advisor to Compliance Operations teams (e.g., Manufacturing, QC, QA, Facilities, Materials Handling, Validation) for maintaining and improving compliance.

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

  • Manages a team with direct oversight of review and/or approval of product complaint investigations and corrective actions.

  • May review and approve system records including complaint investigations and extensions.

  • Approves and reviews procedural revisions.

  • Provides direction for cross-functional study team meetings and interacts with subject matter experts (SMEs).

  • Serves as SME to present topics to management, department personnel, and during inspections.

  • Tracks quality system metrics for evaluation of team performance including complaint investigations, corrective actions, change management, and controlled document workflows.

  • Drafts and implements long-term planning for the process, staff, and budget.

  • Performs personnel management functions (e.g., annual employment evaluations, coaching, mentoring, performance feedback, etc.).

  • Facilitates continuous improvement initiatives specific to function.

  • Ensures that training, policies, and procedures are effectively administered and comply with regulatory requirements and current Good Manufacturing Practices (cGMPs).

  • Other related responsibilities as assigned.

This role may be for you if you:

  • Have previous quality experience in the pharmaceutical industry

  • You continuously seek to improve processes for improved performance

  • Enjoy leading a team of Quality minded professionals

To be considered for this role you must hold a BA/BS degree in Chemistry, Biology, or related field and the following minimum amounts of relevant experience for each level:

  • Manager – 7+ years

  • Senior Manager – 8+ years

Experience preferred in pharmaceutical or medical device, including some supervisory and/or leadership experience. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

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.

Salary Range (annually)

$104,300.00 - $199,000.00