Quality and Compliance Oversight Role
This is a leadership position responsible for ensuring the Raheen site meets quality standards in manufacturing, quality systems, quality control, validation, facilities, and materials management. The role involves overseeing site quality systems, including deviations, CAPA, change control, audits, and customer complaints.
Key Responsibilities:
* Ensure compliance with all aspects of Quality for the Raheen site
* Oversee site quality systems, including deviations, CAPA, change control, audits, and customer complaints
* Review and approve documents related to area functions, such as failure investigations, change control documents, and corrective/preventative action documents
* Approve procedures, policies, and instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
* Monitor and trend metrics for site quality systems
* Manage and develop site risk assessment activities and site risk register
* Participate in continuous improvement initiatives
* Participate in regulatory and customer audits
* Collaborate with functional departments to resolve issues and maintain compliance
* Identify gaps in systems and develop feasible plans for correction
* Train personnel on quality system processes
Requirements:
* BSc/BEng in a scientific discipline or related field
* 7+ years of relevant work experience in the pharmaceutical or other related industry
* Expert GMP knowledge
* Able to work independently or as part of a team
* Self-starter with ability to operate in a multifaceted environment
* Comfortable working on own initiative
Regeneron is an equal opportunity employer and welcomes applications from diverse candidates. We provide comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. Please note that certain background checks will form part of the recruitment process.