Regeneron · 2 weeks ago
Associate Manager, Quality Compliance (External Partners)
Regeneron is a leading biotechnology company focused on innovative medicines. They are seeking an Associate Manager, Quality Compliance to lead a team providing quality assurance oversight of External Partners, ensuring compliance with QMS requirements and supporting regulatory audits.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Managing QA Compliance team with responsibilities of operating as a counterpart to External Manufacturing to provide QA support, review and approval of QMS records including, deviation, CAPA and change control
Managing QMS system associated with External QA operations
Mentoring direct reports and functional area counterparts in compliance requirements
Facilitating continuous improvement initiatives specific to External QA oversight
Ensuring appropriate training programs are executed for QMS systems
Support regulatory and customer audits
Qualification
Required
Bachelor's degree
6+ years of experience for Associate Manager level
7+ years of experience for Manager level
Knowledge of GMP compliance requirements
Experience with electronic GMP documentation systems (Veeva a plus)
Ability to manage QA Compliance team
Ability to mentor direct reports and functional area counterparts in compliance requirements
Ability to facilitate continuous improvement initiatives specific to External QA oversight
Ability to ensure appropriate training programs are executed for QMS systems
Ability to support regulatory and customer audits
Organized with attention to detail
Ability to prioritize multiple assignments and changing priorities
Benefits
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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