Job Title: External Testing Manager
We are seeking a highly motivated and experienced External Testing Manager to join our Quality Control group.
About the Role:
The successful candidate will be responsible for managing and supporting external testing activities within the Quality Control group in support of our company's quality program.
Duties and Responsibilities:
* Organize and schedule external testing to support product release/stability testing under cGMP
* Evaluate and monitor the performance of the contract labs
* Coordinate investigation activities at contract laboratories to ensure thorough technical content and compliant documentation
* Communicate and solicit input from Regeneron SME's and Quality Assurance
* Coordinate the issuance and approval of Quality Agreements with contract labs
* Author Master service Agreements, as necessary
* Participate in GMP audits to the contract labs
* Coordinate and lead quarterly meetings between contract labs and QC management
* Identify and solve technical problems at contract laboratories with QC Management
* Oversee and lead the daily quality control metrics meeting
* Manage 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:
Bachelor of Science (BS) or Bachelor of Arts (BA) in Chemistry, Biology or related field
Experience:
5+ years of experience in Laboratory Management and analytical testing
Salary Range:
$80,000 - $120,000 per year