Medivant Healthcare · 1 month ago
Associate Director - Quality Assurance (MQA)
Chandler, AZ, US
Full-time
Onsite
Lead/Staff, Director/Executive
$120K/yr - $125K/yr
10+ years expMedivant Healthcare is a U.S.-based pharmaceutical manufacturer dedicated to producing high-quality sterile injectables. The Associate Director of QA (MQA) ensures the implementation and maintenance of cGMP standards and oversees quality systems to ensure that all manufactured products meet defined safety and quality requirements.
ManufacturingPharmaceuticalSales
Responsibilities
Ensure implementation and maintenance of current Good Manufacturing Practices (cGMP) and applicable international standards
Ensure the product meets defined standards for strength, identity, safety, purity, and quality
Review corrective and preventive actions (CAPA) aligned with complaints, deviations, and investigation root cause analysis
Review and approve documents including the Site Master File, Validation Master Plan, SOPs, Master Batch Documents, and Validation Protocols
Review and execute validation activities; provide recommendations aligned with regulatory expectations
Guide and support departments during SOP reviews to strengthen the Quality Management System
Review and approve OOS, OOT, Change Controls, Deviations, and ensure investigations use proper root‑cause tools
Ensure implementation of Internal Quality Audit (IQA) schedules across manufacturing facilities
Maintain audit readiness for regulatory authorities and partner audits
Communicate and escalate concerns proactively, suggesting corrective and preventive actions
Qualification
Required
Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or related field
10–15 years of progressive QA experience in sterile or regulated pharmaceutical environments
Strong understanding of cGMP, QMS systems, audits, and regulatory expectations
Experience leading investigations, root cause analysis, and CAPA effectiveness programs
Proven ability to manage documentation systems and regulatory inspection readiness
Preferred
Experience in sterile injectables or aseptic manufacturing
Experience with global regulatory inspections and client audits
Strong communication and leadership capabilities
Benefits
Medical, dental, and vision insurance.
401(k) with employer match.
Paid time off, sick leave, and holidays.
Professional development and leadership‑growth 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
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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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