Medivant Healthcare ยท 2 months ago
Associate Director of Quality Assurance
Phoenix, AZ, US
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$100K/yr - $125K/yr
7+ years expMedivant Healthcare is a U.S.-based pharmaceutical manufacturer specializing in sterile injectable generic medications. The Associate Director of Quality Assurance oversees the quality systems and compliance programs to ensure adherence to FDA and cGMP standards while leading QA personnel in daily oversight of production and internal audits.
ManufacturingPharmaceuticalSales
Responsibilities
Provide strategic and operational leadership for the Quality Assurance department across both Chandler and Deer Valley sites
Oversee batch record review, product disposition, deviation management, and CAPA systems
Ensure compliance with FDA 21 CFR Parts 210/211, cGMP, and ISO 9001 requirements
Lead internal audits and support external regulatory inspections (FDA, DEA, State Board of Pharmacy, etc.)
Drive continuous improvement initiatives in QA processes, documentation, and systems
Collaborate with Manufacturing, QC, and Validation teams to maintain compliance and resolve quality issues promptly
Approve and oversee training programs related to cGMP and aseptic practices
Maintain QA oversight for sterile operations, cleanroom environmental monitoring, and process validation
Review and approve SOPs, protocols, and validation documentation
Support investigations and risk assessments for deviations and product quality issues
Mentor and develop QA staff to ensure consistent performance and professional growth
Qualification
Required
Bachelor's degree in Chemistry, Microbiology, Pharmacy, or related scientific discipline
Minimum 7+ years of Quality Assurance experience in a pharmaceutical or FDA-regulated manufacturing environment
Strong working knowledge of FDA regulations, cGMP, and quality systems
Proven leadership experience managing QA teams or quality systems
Excellent communication, documentation, and analytical skills
Preferred
Experience in sterile injectable manufacturing, 503B, or aseptic fill-finish operations
Advanced degree (MS, PharmD, or MBA)
Experience with quality management systems (QMS) and regulatory inspections
Familiarity with LIMS, ERP, or electronic batch record systems
Benefits
Annual performance-based bonus.
Medical, dental, and vision insurance.
401(k) with employer match.
Paid time off, holidays, and professional development opportunities.
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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