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Job Description
Manage external testing activities, coordinate with contract laboratories, and ensure compliance with quality standards.
The successful candidate will oversee the Quality Control group's external testing activities, supporting the company's quality program. A typical day might include:
- 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
This role requires:
- Current or prior experience working in a regulated environment
- Proven ability to work independently or as part of a team
- Strong trouble-shooting and problem solving skills
To be considered, you should have a BS/BA in Chemistry, Biology or related field with 5+ years of experience in Laboratory Management and analytical testing and some previous supervisory/leadership experience.