Job Description
A summary of the role: Manage document control and archives operations, oversee workflows, records issuance, and inspection support. Lead direct reports, establish goals, and ensure timely prioritization of work. Provide metrics, coaching, and guidance to employees. Site lead for Doc Control global teams and interface with regulatory inspectors. Provide advice on document format and style, and lead organizational design and doc control requirements.
Responsibilities
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* Manage direct reports and establish goals
* Oversee document workflows, records issuance, and inspection support
* Ensure timely prioritization of work and adequate resource availability
* Provide metrics and coaching to employees
* Site lead for Doc Control global teams and projects
* Interface with regulatory inspectors and provide advice on document format and style
* Lead organizational design and doc control requirements
Requirements
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* BA/BS in Science, Engineering, Technology
* 8+ years of experience in a cGMP environment
* People management and/or team leadership experience
* Strong knowledge of equipment used for QC analysis and operations
* Familiarity with site change control, risk management, and data integrity initiatives
Regeneron is an equal opportunity employer and provides comprehensive benefits including health and wellness programs, equity awards, and paid time off.