Change Control Specialist (Technical Operations)

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 functional expertise. Typical responsibilities include: Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPA’s) 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. We might be looking for someone who: Exceeds expectations in a quality-driven organization. Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills. Has a strong attention to detail. Has strong technical writing and interpersonal communication skills. Enjoys working in a fast-paced environment. Has experience navigating a controlled quality system (preferred but not required). Education and Experience Must hold a Bachelor’s degree in Life Sciences, Engineering or a related field. Relevant experience amounts for each level: Associate Specialist – 0-2 years; Specialist – 2+ years; Sr Specialist – 5+ years. May substitute proven experience for education requirement. 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 Regeneron Pharmaceuticals, Inc (USA)