Associate Manager, Quality Compliance (External Partners) jobs in United States
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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
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Comp. & Benefits
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H1B Sponsor Likelynote

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

GMP complianceQMS managementDeviation reportingElectronic GMP systemsContinuous improvementAttention to detailOrganizational skillsMentoring

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

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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 Company
Total Funding
$15.93M
Key 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

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase