CMC Product Quality Compliance Specialist (Distribution Compliance) ID-11125

The CMC Product Quality Compliance Clinical Distribution team is hiring! The QA Associate Specialist supports QP certification activities with the ultimate goal of supplying EU and UK clinical studies. This position works closely with regulatory, clinical distribution supply logistics, supply planning teams, and contract manufacturing organization Qualified Persons.

In this role, a typical day may include:
Working collaboratively with CMC team members, regulatory, quality, and supply planning cross-functional teams to ensure continuity of clinical supply

Supporting distribution compliance through obtaining appropriate GMP source documentation and ensuring compliance to GMP and approved regulatory filings

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Compilation of a documentation package to support QP certification

Review, edit, approve or coordinate workflow of Regeneron controlled documents

Responding to queries from QPs or cross-functional teams to support timely QP certification and supply of clinical studies

Coordination of document completion across cross-funcational teams in preparation for regulatory submissions

Continually evaluating Regeneron processes and procedures with a focus on quality, compliance, and continuous improvement

This role may be the right fit for you if you:
Good organizational skills and attention to detail

Requires excellent written, verbal, and interpersonal skills and the ability to effectively interact cross-functionally

Ability to handle multiple assignments and changing priorities

Ability to learn and use computerized systems for performance of daily tasks

Ability to prioritize across multiple tasks, and meet deadlines
To be considered for this role, you must hold a Bachelor’s degree in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience for each level:
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