Compliance Specialist (External Manufacturing)
We are currently looking to fill a Compliance Specialist, External Manufacturing position. This position is a member of the External Manufacturing Team and is responsible for operations support and compliance related activities for the manufacture of Regeneron products.
In this role, a typical day might include the following:
Leading and handling deviation investigations, CAPAs, and change controls
Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement
Generating and tracking performance metrics
Maintaining knowledge of current good manufacturing practices (cGMPs)
Conducting periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
Maintaining required training status on Regeneron specific work instructions and SOPs
Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers
Continuous Process Improvement Implementation
This role may be for you if you:
Have knowledge of drug product manufacturing from formulation through the final package
Possess basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
Exhibit confidence, have a high emotional IQ, and have strong interpersonal, written and oral communication skills for providing team updates
Like collaborating with external vendors and partners
Enjoy travel to contract manufacturers or business partners, as the need arises (25% or less)
To be considered for this role you must hold a Bachelor’s degree in scientific discipline and the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial drug products) for each level:
Associate Compliance Specialist: 0-2+ years
Compliance Specialist: 2+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.