Quality Control Manager Job Description
The role of Quality Control Manager involves overseeing the daily operations of Quality Control support activities.
Key Responsibilities:
* Maintaining oversight of QC equipment lifecycle activities, including procurement, installation, qualification, maintenance, and decommissioning
* Providing direction to Managers and staff that support the equipment
* Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements
* Interacting with QC partner groups to establish internal requirements for equipment
* Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups
* Managing oversight of the preventive and corrective maintenance monitoring program
* Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories
* Supervising the issuance and approval of Quality agreements and SLAs with the contract labs
* Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization
* Identifying and calling out issues at contract laboratories to QC leadership
* Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction
* Travel may be required in support of external contract laboratory testing activities
* Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations
* Responsibility for equipment automation and associated projects
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-orientated approach
Qualifications:
* Bachelor's degree in chemistry, biology or related field
* 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry
* Previous supervisory or leadership experience
Benefits:
* Comprehensive benefits package
* Health and wellness programs (including medical, dental, vision, life, and disability insurance)
* Fitness centers
* 401(k) company match
* Family support benefits
* Equity awards
* Annual bonuses
* Paid time off
* Paid leaves (e.g., military and parental leave)
Work Environment:
Regeneron is an equal opportunity employer. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S. positions.