Senior QA Regulatory Compliance Specialist

 The Senior QA Regulatory Compliance Specialist uses Quality Assurance and Regulatory expertise within the drug development industry. This role ensures compliance between GMP documentation and the approved regulatory submission for clinical and commercial material product distributed globally.

As a Senior QA Specialist, a typical day might include the following:

• Evaluating and providing quality oversight of the distribution compliance documentation for clinical and commercial release.
• Leading the coordination and compliance of key deliverables from internal and external partners in a timely manner to ensure product supply.
• Managing and maintaining relationships with internal and external customers, including partners and collaborators, to support clinical and commercial distribution.
• Defining and implementing quality processes and systems for maintaining regulatory compliance for clinical and commercial operations as the QA Distribution Compliance team evolves.
• Collecting data and reporting metrics for the QA Distribution Compliance team.
• Identifying and implementing continuous improvement initiatives.
• Performing other support responsibilities as requested.
• May have direct reports.

To be considered for the Sr Quality Compliance Specialist position you must have a Bachelor’s in a scientific or engineering subject area or related field with a minimum of 5+ years of experience in pharmaceutical/biotechnology or related industry. 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.