About Medivant Healthcare
Medivant Healthcare is a U.S.-based pharmaceutical manufacturer specializing in sterile injectable generic medications for hospitals and healthcare providers nationwide. Operating from FDA-registered facilities in Chandler and Deer Valley, Arizona, Medivant is dedicated to producing safe, high-quality, and affordable pharmaceuticals that meet the highest standards of cGMP and FDA compliance.
Position Summar
yThe Director of Quality Assurance provides strategic leadership and direction for all aspects of Medivant’s quality systems, compliance, and regulatory operations. This role ensures adherence to FDA, DEA, cGMP, and USP regulations while fostering a strong culture of quality across the organization
.
The Director will oversee QA teams at both production sites, manage regulatory inspections, drive continuous improvement initiatives, and ensure that all products meet Medivant’s commitment to excellence and patient safet
y.
Experience in sterile injectable manufacturing or aseptic operations is requir
ed.
Key Responsibili
- tiesLead and manage the Quality Assurance department, including quality systems, document control, and compliance functi
- ons.Serve as the company’s primary quality authority for all cGMP-related matters, including product release and regulatory inspecti
- ons.Oversee batch review, deviation investigations, CAPA programs, and change contr
- ols.Ensure adherence to 21 CFR Parts 210/211, USP <797>/<800>, and other applicable regulati
- ons.Lead and support external audits, including FDA, DEA, and State Board of Pharmacy inspecti
- ons.Collaborate with Manufacturing, QC, Validation, and Regulatory Affairs to maintain compliance throughout the product lifecy
- cle.Review and approve SOPs, validation protocols, and quality-related documentat
- ion.Establish and maintain an effective Quality Management System (QMS) and metrics tracking prog
- ram.Drive initiatives for continuous improvement and risk mitigation across quality proces
- ses.Provide leadership, training, and mentorship to QA staff to ensure competency and alignment with Medivant’s standa
- rds.Represent the company in regulatory discussions and serve as a key decision-maker for compliance matt
ers.
Qualifica
- tionsBachelor’s degree in Chemistry, Microbiology, Pharmacy, or related scientific f
- ield.Minimum 10+ years of progressive Quality Assurance experience in pharmaceutical manufacturing, with at least 5 years in sterile injectable or aseptic operat
- ions.In-depth knowledge of FDA, cGMP, USP, and ICH guidel
- ines.Proven success managing regulatory inspections and quality sys
- tems.Demonstrated leadership in building and developing QA t
- eams.Strong analytical, problem-solving, and communication sk
ills.Prefe
- rred:Master’s degree or higher in a scientific or regulatory discip
- line.Experience in 503B outsourcing, sterile fill-finish, or parenteral drug produc
- tion.Familiarity with LIMS, ERP, and electronic QMS platf
- orms.Certification in Quality Management (ASQ-CQA, CQM/OE) or Six S
igma.
Work Envir
- onmentOnsite role across both Chandler and Deer Valley facilities. Includes office and cleanroom exposure as part of quality oversight. Standard weekday schedule, with flexibility during audits or production rel
eases.
Compensation & B
- enefitsSalary Range: $130,000 – $150,000 annually, based on expe
- rience.Annual performance-based bonus eligi
- bility.Comprehensive health, dental, and vision co
- verage.401(k) with employer
- match.Paid time off, holidays, and professional development pr
ograms.
