Summary: This position implements policies and procedures to review and approve validation/qualification documentation for equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Oversight Specialists.
Essential Duties and Responsibilities include, but are not limited to, the following:
Leads a technical Quality review team by developing appropriate plans, schedules, resource loading, developing Validation best practices, standards and guidelines.
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 that execute protocols and draft associated deviations and final reports.
Approves various documents relating to area function, including those listed above.
Provide direction and assign work to Validation Oversight Specialists to meet goals and timings
Coordinates prioritization of activities with area management.
Participates in regulatory and customer activities.
Collaborates with functional departments to resolve issues.
Manages projects and prepares status reports.
Education and Experience:
Requires a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 7+ years of related experience within the field; may consider substituting relevant experience for education.
Experience leading, supervising, or managing others required.
#LI-Onsite #IREADV #JOBSIEPR #REGNIEQA
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.