Change Control Specialist (Technical Operations)

Change Control Specialist – Technical Operations Compliance We are currently looking to fill a Change Control Specialist position in our growing Technical Operations Compliance team. This position develops strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise. Key Responsibilities Craft business plans to independently advance change control initiatives to implement Corrective and Preventive Actions (CAPAs) and process improvements in support of manufacturing operations Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change Review, edit, and revise controlled documentation in accordance with cGMP standards Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner Present business critical and regulatory impactful change controls to senior leadership Document all training Assist with the training of new employees May manage direct reports Who Is a Good Fit? Excel in a quality driven organization. Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills. Have a strong attention to detail. Have strong technical writing and interpersonal communication skills. Enjoy working in a fast‑paced environment. Have experience navigating a controlled quality system (preferred but not required). Qualifications To be considered for this role you must hold a Bachelor’s degree in Life Sciences, Engineering or related field and meet the following minimum relevant experience for each level: Associate Specialist – 0-2 years Specialist – 2+ years Sr Specialist – 5+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Benefits and Compensation We offer a competitive and comprehensive total rewards package that may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit Salary Range (annually) $67,400.00 - $110,000.00 Equal Opportunity Statement 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. #J-18808-Ljbffr SwiftCruit