Medivant Healthcare · 2 months ago
Director Of QA
Phoenix, AZ, US
Full-time
Onsite
Director/Executive
$130K/yr - $150K/yr
10+ years expMedivant Healthcare is a U.S.-based pharmaceutical manufacturer specializing in sterile injectable generic medications. The Director of Quality Assurance will provide strategic leadership for quality systems and regulatory operations, ensuring compliance with FDA and cGMP regulations while fostering a culture of quality across the organization.
ManufacturingPharmaceuticalSales
Responsibilities
Lead and manage the Quality Assurance department, including quality systems, document control, and compliance functions
Serve as the company’s primary quality authority for all cGMP-related matters, including product release and regulatory inspections
Oversee batch review, deviation investigations, CAPA programs, and change controls
Ensure adherence to 21 CFR Parts 210/211, USP <797>/<800>, and other applicable regulations
Lead and support external audits, including FDA, DEA, and State Board of Pharmacy inspections
Collaborate with Manufacturing, QC, Validation, and Regulatory Affairs to maintain compliance throughout the product lifecycle
Review and approve SOPs, validation protocols, and quality-related documentation
Establish and maintain an effective Quality Management System (QMS) and metrics tracking program
Drive initiatives for continuous improvement and risk mitigation across quality processes
Provide leadership, training, and mentorship to QA staff to ensure competency and alignment with Medivant’s standards
Represent the company in regulatory discussions and serve as a key decision-maker for compliance matters
Qualification
Required
Bachelor's degree in Chemistry, Microbiology, Pharmacy, or related scientific field
Minimum 10+ years of progressive Quality Assurance experience in pharmaceutical manufacturing, with at least 5 years in sterile injectable or aseptic operations
In-depth knowledge of FDA, cGMP, USP, and ICH guidelines
Proven success managing regulatory inspections and quality systems
Demonstrated leadership in building and developing QA teams
Strong analytical, problem-solving, and communication skills
Preferred
Master's degree or higher in a scientific or regulatory discipline
Experience in 503B outsourcing, sterile fill-finish, or parenteral drug production
Familiarity with LIMS, ERP, and electronic QMS platforms
Certification in Quality Management (ASQ-CQA, CQM/OE) or Six Sigma
Benefits
Annual performance-based bonus eligibility.
Comprehensive health, dental, and vision coverage.
401(k) with employer match.
Paid time off, holidays, and professional development programs.
Company
Medivant Healthcare
Medivant Healthcare is a boutique, cGMP compliant manufacturer.
51-200 employees
H1B Sponsorship
Medivant Healthcare 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 (35)
2024 (13)
2023 (4)
2022 (6)
2021 (5)
2020 (1)
Funding
Current Stage
Growth StageRecent News
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