Join to apply for the Manager Quality Control role at Regeneron
Within this role you will be responsible for the oversight of Quality Control support operations.
Typical 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, qualified and available for QC laboratory usage
* 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, 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
* Performing personnel management functions including timesheet submissions, scheduling of vacations, personnel development, and performance evaluations
* Responsibility for equipment automation and associated projects
Desired qualifications and attributes
* Strong communication and interpersonal skills
* Logical troubleshooting and problem‑solving skills
* 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
To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years’ proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience.
Salary and benefits
In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) 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 (or lack thereof), 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. The Company will also provide reasonable accommodation to 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.
Seniority level
* Mid‑Senior level
Employment type
* Full‑time
Job function
* Management
* Biotechnology
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