Summary: A technical quality leader who improves systems and coaches/facilitates activities while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Responsible for overseeing a team of QA employees and their prospective area(s) and/or assignments

As an Associate Manager or Manager in QA Operations, a typical day may include:

• Represent the IOPS organization on behalf of QA with external partners and suppliers to communicate IOPS QA policy and procedures; liaise with external partners and provide QA expertise i.e. provide QA Oversight of Contract Manufacturing Organisations (CMO’s)

• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution

• Provide QA Oversight on New Production Introductions, Tech Transfer activities

• Supervise, train and/or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization

• Ensures global alignment of processes, procedures, methods and projects

• Provides consultation or advice in alignment with QA policies

• Review, edit, or approve Regeneron controlled documents

• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement

• Organise QA resources assigned to functional area to meet goals and timings, coordinate prioritization of activities with area management.

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

• Review customer requirements and implement required processes, as needed, to meet customer expectations regarding Quality.

• Participates in regulatory and customer audits

• Activities may be on the floor or at a desk

This role may be for you if:

• Understanding of biologics manufacturing operations is preferred

• Possesses a high level of expertise within the QA organisation

• Good organizational skills and attention to detail

• Good process management skills to accurately scope out / support projects

• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally

• Capable of representing IOPS in external interactions and negotiating

• Positive, proactive approach to drive assignments/tasks to completion

• Ability to handle multiple assignments and changing priorities

• Knows the technology, has a good sense of perspective to plan for the future

• Ability to learn and utilize computerized systems for daily performance of tasks

• Ability to prioritize, manage multiple tasks, and meet deadlines; courage to change and embrace change

• Ability to resolve conflict with tact and diplomacy

• Capable of representing IOPS in external interactions and negotiating

To be considered for this position you must hold a BS/BA in scientific discipline or related field and minimum 8 years relevant experience. Relevant experience may be substituted for education requirement.

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.