**Job Title:** Quality Control Manager
About the Role:
We are seeking a highly skilled Quality Control Manager to oversee our Quality Control support operations. As a key member of our team, you will be responsible for maintaining oversight of QC equipment lifecycle activities, providing direction to Managers and staff, ensuring equipment qualification and maintenance programs meet regulatory requirements, and managing preventive and corrective maintenance monitoring programs.
Responsibilities:
* Maintain oversight of QC equipment lifecycle activities, including procurement, installation, qualification, maintenance, and decommissioning.
* Provide direction to Managers and staff that support the equipment.
* Ensure equipment qualification and maintenance programs are aligned with regulatory agencies' requirements, qualified, and available for QC laboratory usage.
* Interact with QC partner groups to establish internal requirements for equipment.
* Manage QC equipment validation/qualification efforts through partnering and interaction with QA Validation and IT groups.
* Manage oversight of the preventive and corrective maintenance monitoring program.
* Supervise the issuance and approval of Quality agreements and SLAs with contract labs.
* Verify that the site Manufacturing license and global procedures reflect current contract lab utilization.
* Identify and call out issues at contract laboratories to QC leadership.
* Sourcing, coordinating, and project management of GMP activities relating to new contract lab introduction.
* Travel may be required in support of external contract laboratory testing activities.
* Perform personnel management functions, including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
Requirements:
* Possess strong communication and interpersonal skills.
* Demonstrate logical troubleshooting and problem-solving skills.
* Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms.
* Have the ability to communicate effectively with multiple partners.
* Enjoy working in a fast-paced environment.
* Demonstrate a collaborative and team-oriented approach.
Education and Experience:
A BA/BS in chemistry, biology, or related field is required. 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience are preferred.
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 (e.g., military and parental leave) for eligible employees at all levels.
Contact Information:
Please speak with your recruiter for more information about Regeneron's on-site policy and expectations for this role and your location.