Quality Control Manager Role
In this role, you will oversee the support operations of Quality Control. Responsibilities include maintaining oversight of QC equipment lifecycle activities, providing direction to staff, and ensuring equipment qualification and maintenance programs align with regulatory requirements.
Duties:
* Maintain oversight of QC equipment lifecycle activities (procurement, installation, qualification, maintenance, decommissioning)
* Provide direction to managers and staff that support the equipment
* Ensure equipment qualification and maintenance programs are aligned with regulatory agencies' requirements
* Interact with QC partner groups to establish internal requirements for equipment
* Lead QC equipment validation/qualification efforts through partnering and interaction with QA Validation and IT groups
* Manage oversight of preventive and corrective maintenance monitoring program
* Manage oversight of QC external laboratories activities and performance monitoring of external testing laboratories
* Supervise the issuance and approval of Quality agreements and SLAs with contract labs
* Verify that site Manufacturing licence and global procedures reflect current contract lab utilization
* Identify and call out issues at contract laboratories to QC leadership
* SOURCE GMP activities relating to new contract lab introduction
* Travel may be required in support of external contract laboratory testing activities
Responsibilities:
* Perform 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
* Ability to communicate effectively with multiple partners
* Enjoy working in a fast-paced environment
* Collaborative and team-orientated approach
Education and Experience:
* Bachelor's degree in chemistry, biology, or related field
* 8+ years proven experience preferably in pharmaceutical or biotechnology industry
* Previous supervisory or leadership experience
Work Environment:
Regeneron offers an inclusive and diverse culture that provides comprehensive benefits which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.