The Senior QA Compliance Specialist, QA Distribution Compliance 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. This position works collaboratively with alliance partners, collaborators and CMOs to ensure regulatory compliance for global distribution.
As a Senior QA Compliance Specialist, QA Distribution Compliance, a typical day may include the following:
- Ensuring drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
- Implementing relationship management with internal and external customers, including partners and collaborators, to support clinical and commercial distribution.
- Managing the coordination and compliance of key deliverables from internal and external partners in a timely manner to ensure product supply.
- Developing and implementing procedures and systems for maintaining regulatory compliance for clinical and commercial operations as the QA Distribution Compliance team evolves.
- Collaborating cross-functionally to support regulatory release process and inventory review.
- Identifies and implements continuous improvement initiatives.
- Performs other support responsibilities as requested.
This role may be for you if you have:
- Experience preferably pharmaceutical or medical device.
- Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
- Consistent record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
- Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
To be considered for this role you must hold a BA/BS in a scientific or related field and a minimum of 5 years relevant experience in the pharmaceutical/biotechnology or related industry (or MS with 3 5 years of relevant experience)/ 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 eligible 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 parental 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.