Associate Director
2 days ago
About Medivant Healthcare
Medivant Healthcare is a U.S.-based pharmaceutical manufacturer dedicated to producing high‑quality sterile injectables for hospitals and healthcare facilities nationwide. Operating from FDA‑inspected facilities in Arizona, Medivant is committed to compliance, operational excellence, and continuous improvement.
Position Summary
The Associate Director of QA (MQA) ensures the implementation and maintenance of cGMP standards, oversees quality systems, and ensures that all manufactured products meet defined safety, identity, strength, purity, and quality requirements. This role provides leadership across compliance systems, investigations, documentation, internal audits, and regulatory readiness activities.
Key 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.
Qualifications
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.
Work Environment & Physical Requirements
- Full‑time onsite position at Chandler and Deer Valley facilities.
- May include time spent in classified cleanroom environments following gowning requirements.
- Ability to stand for extended periods and lift up to 25 lbs, as needed during audits or oversight activities.
Compensation & Benefits
- Competitive salary based on experience.
- Medical, dental, and vision insurance.
- 401(k) with employer match.
- Paid time off, sick leave, and holidays.
- Professional development and leadership‑growth opportunities.
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