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Associate Manager, QA Investigations jobs in United States
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Regeneron · 5 hours ago

Associate Manager, QA Investigations

Regeneron Pharmaceuticals is currently seeking an Associate Manager for QA Investigations. This role is responsible for overseeing the quality review and approval of deviation events, investigations, and corrective actions, while managing a team to ensure compliance with regulatory requirements and good manufacturing practices.
BiotechnologyPharmaceuticalBiopharma
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Manages a team with direct oversight of review and approval for deviations, laboratory investigations and corrective actions
May review, verify and approve system records
Collaborates across QA to provide succinct support to investigation teams to drive quality outcomes
Approves and reviews SOP revisions
Provides direction for cross-functional study team meetings and interacts with subject matter authorities
Provides input for error prevention and corrective actions based on investigational findings
Involved in post-production management of events as required to facilitate closures to meet the required timelines
Serves as a subject matter authority to present topics to management and during inspections
Monitors quality system metrics including deviations, corrective actions, change management and controlled document workflows
Drafts and implements long-term planning for the process, staff and budget
Performs personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.)
Makes decisions and develops and implements policies
Ensures that policies and procedures are effectively coordinated and follow regulatory requirements and current good manufacturing practices (cGMPs)

Qualification

CGMP manufacturing experienceQuality Assurance oversightDeviation managementSupervisory experienceLife Sciences degreeProcess improvementTeam leadershipCollaboration skills

Required

BA / BS degree in Life Sciences or related field
6+ years of relevant cGMP manufacturing experience
3 years of supervisory experience

Preferred

Previous quality experience in the pharmaceutical industry
Continuous improvement mindset for processes
Enjoy leading a team of Quality minded professionals

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