What are the responsibilities and job description for the Associate Director of Quality Assurance position at Tailstorm Health Inc?
About Medivant Healthcare
Medivant Healthcare is a U.S.-based pharmaceutical manufacturer specializing in sterile injectable generic medications for hospitals, clinics, and healthcare systems nationwide. Operating from FDA-registered facilities in Chandler and Deer Valley, Arizona, Medivant is committed to manufacturing excellence, regulatory compliance, and the delivery of affordable, high-quality injectables to healthcare providers.
Position Summary
The Associate Director of Quality Assurance oversees Medivant’s quality systems and compliance programs to ensure adherence to FDA, cGMP, USP, and ISO standards. This role is responsible for maintaining a strong quality culture across manufacturing and laboratory operations while leading QA personnel in daily oversight of production, batch release, and internal audits.
Experience with sterile injectables and aseptic manufacturing environments is strongly preferred.
Key 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.
Qualifications
- 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.
Work Environment
Onsite role at Chandler and Deer Valley facilities, with some inter-site travel required. Office and cleanroom environment exposure as part of routine QA oversight. Monday–Friday, full-time position with occasional weekend or after-hours support during audits or production activities.
Compensation & Benefits
- Salary Range: $100,000 – $125,000 annually, based on experience.
- Annual performance-based bonus.
- Medical, dental, and vision insurance.
- 401(k) with employer match.
- Paid time off, holidays, and professional development opportunities.
Salary : $100,000 - $125,000