Job Description
The successful candidate will manage and support the external testing activities within the Quality Control group in support of the company's quality program.
Responsibilities:
* Organizing and scheduling external testing to support product release/stability testing under cGMP.
* Managing external data review per production schedule and stability program.
* Performing the single point of contact role with contract laboratory facilities.
* Evaluating and monitoring the performance of the contract labs.
* Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation.
* Communicating and soliciting input from Regeneron SME's and Quality Assurance.
* Coordinating the issuance and approval of Quality Agreements with contract labs.
* Authoring Master service Agreements, as necessary.
* Participating in GMP audits to the contract labs.
* Coordinating and leading quarterly meetings between contract labs and QC management.
* Identifying and solving technical problems at contract laboratories with QC Management.
* Oversees and leads the daily quality control metrics meeting.
* Managing compliance items and metrics within the group.
Requirements:
* Current or prior experience working in a regulated environment.
* A proven ability to work independently or as part of a team.
* Strong trouble-shooting and problem-solving skills.
Education and Experience:
Bachelor's degree in Chemistry, Biology or related field. 5+ years of experience in Laboratory Management and analytical testing. Previous supervisory/leadership experience is also required.