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Manager QA Validation - External Partners

Job Description

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The QA Validation department at Regeneron is adding to their team! The Manager QA Validation - External Partners leads a department responsible for the qualification of the equipment, systems, and processes validation for our CMO and partner groups in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

In this role, a typical day may include:

  • Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.

  • Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results.

  • Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports

  • Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs

  • Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

  • Approves various documents relating to area function, including those listed above.

  • Provide direction and assign work to Validations Specialists to meet goals and timings

  • Coordinates prioritization of activities with area management.

  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.

  • Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.

  • Participates in regulatory and customer activities.

  • Collaborates with functional departments to resolve issues.

  • Manages projects and prepares status reports.

  • Some travel may be required (approximately 25%)

To be considered for this role you must hold a Bachelor's degree in Engineering, Chemistry or Life Sciences and the following minimum amounts of experience for each level:

  • Manager: 7+ years

  • Sr. Manager 8+ years

May substitute proven experience for education requirement.

#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