Job Title: Quality Control Manager
In this critical role, you will oversee the entire quality control function to ensure compliance with regulatory requirements and industry standards.
Responsibilities:
* Maintain oversight of equipment lifecycle activities, including procurement, installation, qualification, maintenance, and decommissioning
* Provide direction to teams responsible for equipment support and management
* Ensure equipment qualification and maintenance programs align with regulatory agency requirements
* Interact with partner groups to establish internal requirements for equipment
* Lead equipment validation and qualification efforts through partnering and interaction with QA and IT groups
* Manage preventive and corrective maintenance monitoring programs
* Supervise external laboratory activities and performance monitoring
* Issue and approve Quality agreements and SLAs with contract labs
* Verify site manufacturing license and global procedures reflect current contract lab utilization
* Identify and address issues at contract laboratories
* SOURCE, COORDINATE, AND MANAGE GMP ACTIVITIES RELATED TO NEW CONTRACT LAB INTRODUCTION
* Perform personnel management functions, including time sheet submissions, vacation scheduling, personnel development, and performance evaluations
* Oversee equipment automation and associated projects
Requirements:
* BA/BS in Chemistry, Biology or related field
* 8+ years' proven experience preferably in pharmaceutical or biotechnology industry
* Previous supervisory or leadership experience
* Strong communication and interpersonal skills
* Logical troubleshooting and problem-solving skills
* Ability to communicate effectively with multiple partners
* Collaborative team-oriented approach
Benefits:
Regeneron offers a comprehensive benefits package that includes health and wellness programs, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves. Benefits may vary by location.
What We Offer:
* A collaborative and inclusive work environment
* Opportunities for professional growth and development
* Recognition and rewards for outstanding performance