Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.
Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.
Summary: Maintains site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
- Administration and oversight of site quality systems including but not limited to;
– Change Control
– Customer Complaints
– Quality Risk Management
- Responsible for review of the following types of documents, relating to area functions:
– failure investigations
– change control documents
– corrective/preventative action documents
– standard operating procedures
- Maintaining electronic systems used for Change Control and Deviation Management
- Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
- Provision of monitoring and trending metrics associated with site quality systems
- Actively participate in continuous improvement initiatives.
- Participates in regulatory and customer audits.
- Participates in quality risk assessments.
- Collaborates with functional departments to resolve issues and maintain compliance
- Identify gaps in systems and develop feasible plans for correction
- Training of personnel on quality system processes
Education and Experience:
- BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry.
- 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.