200+ applicantsPosted by Agency
The Lotus Group LLC ยท 3 days ago
Director of Quality Assurance
United States
Full-time
Hybrid
Director
10+ years exp
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Hiring Manager
Bill Emker
Insider Connection @The Lotus Group LLC
Responsibilities
Lead inspection readiness, including mock inspections and on-site regulatory support; manage GMP evaluations for the global supply chain.
Ensure regulatory compliance for manufacturing operations globally, liaising with regulatory agencies.
Contribute to global QA strategies and drive quality improvement initiatives with external suppliers.
Collaborate with cross-functional teams to ensure GMP quality and compliance, including vendor selection and CAPA management.
Stay updated on cGMP regulations, train staff, and develop a culture of quality and integrity.
Lead risk management, remediation activities, and continuous improvement to enhance the organization's Quality Management System.
Qualification
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Required
Bachelor's Degree required
10+ years in QA management or regulatory authority with demonstrated success
7+ years managing quality in a regulated global healthcare setting
Strong experience in pharmaceuticals, medical devices, or related fields, including direct interactions with global health authorities
Expertise in continuous improvement, change management, and quality management principles
Preferred
Master's Degree preferred
Company
The Lotus Group LLC
The Lotus Group LLC is a certified minority women-owned (MWBE) business delivering biometrics recruiting services nationally.
11-50 employees
H1B Sponsorship
The Lotus Group LLC 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
Trends of Total Sponsorships
2023 (4)
2022 (2)
2021 (8)
2020 (5)
Funding
Current Stage
Early StageLeadership Team
Helena Fan
Co-Founder and Sr. Partner of Recruiting
Jo Shui
Senior Partner, Recruiting and Operations
Company data provided by crunchbase
