QA Material & Supplier Specialist - External Liaison

The QA Material & Supplier Specialist - External Liaison performs activities in support of the quality oversight of raw materials associated with Regeneron External Entities (Contract Manufacturing Organizations (CMOs), Partners, etc.) while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

The day to day duties include, but are not limited to, the following:

• Review/approval of new raw material requests for raw materials used at Regeneron External Entities
• Review/approval of internal and external changes relating to raw materials used at Regeneron External Entities
• Participation in and/or review of investigations associated with raw materials and related events external to Regeneron
• May contribute to the review of Supplier contracts
• Establishing, reviewing, and editing Regeneron controlled documents
• Represent Quality Assurance in support of deviations, change controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Provides consultation or advice in alignment with policies and procedures
• Work with external departments/companies as a Subject Matter Expert for processes/procedures within the Material & Supplier Quality function
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement; identify gaps in systems and develop feasible plans for correction.

Knowledge, skills, and abilities:

• Excel in a quality driven organization
• Understanding of biologics manufacturing operations is preferred
• Organized individual with attention to detail
• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally
• Ability to navigate changing priorities
• Ability to learn and use computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines

Education and Experience:

• Associate Specialist: BS/BA in scientific subject area or related field and minimum 1-3 years relevant experience
• Specialist; Requires BS/BA in scientific subject area or related field and minimum 3-5 years relevant experience
• Senior Specialist; Requires BS/BA in scientific subject area or related field and minimum 6 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 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.