Senior QA Regulatory Compliance Specialist
Company: Regeneron Pharmaceuticals
Posted on: May 4, 2022
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
- 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
- Identifying and implementing continuous improvement
- 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.
Keywords: Regeneron Pharmaceuticals, Troy , Senior QA Regulatory Compliance Specialist, Other , Troy, New York
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