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Director of Quality Assurance and Compliance

2 months ago

Chandler, Arizona, United States Medivant Healthcare Full time
Job Summary

We are seeking an experienced Quality Assurance Manager to oversee and enhance the quality assurance processes within our 503b compounding facility. The ideal candidate will ensure compliance with regulatory requirements, drive continuous improvement, and maintain the highest quality standards for our compounded medications.

Key Responsibilities
  • Regulatory Compliance: Ensure implementation and maintenance of current Good Manufacturing Practice (cGMP) standards and all applicable international quality standards in the plant.
  • Product Quality: Ensure that the product meets the defined standards for strengths, identity, safety, purity, and quality by various system-driven approaches.
  • Corrective and Preventive Actions: Review and implement corrective and preventive actions in line with root cause analysis for complaints and non-conformities to minimize chances of such re-occurrences.
  • Document Review and Approval: Review and approve documents like Site Master file, Validation Master Plan, Standard Operating procedures, Master Batch Document, and Validation Protocols before implementation.
  • Validation Activities: Review and execute validation activity and give suggestions for enhancement or improvement in line with the current regulatory expectations, if required.
  • Quality Management Systems: Guide and suggest any changes to various departments during SOP review to upgrade and improve quality management systems, in line with current regulatory expectations.
  • Investigation Reports: Ensure review and approval of investigation reports for Out of Specification (OOS), Out of Trend (OOT), Change Control Management (CCM), Deviation, and to ensure that adequate investigation is performed using required tools to derive the root cause and Corrective and Preventive Action.
  • Internal Quality Audit: Ensure the implementation of Internal Quality Audit (IQA) schedule for manufacturing facilities of the company.
  • Audit Readiness: Ensure and sustain all-time audit-ready plant in line with current regulatory expectations for regulatory authorities and other partner inspections.
  • Communication and Escalation: Communicate and escalate well in advance about any observations or concerns observed in any of the processes or systems to respective departments and suggest corrective and preventive actions.
Qualifications
  • Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field; advanced degree or certification (e.g., CQE) preferred.
  • Experience: Minimum of 5 years of experience in quality assurance, with at least 2 years in a managerial role within a compounding or pharmaceutical environment.
  • Regulatory Knowledge: In-depth knowledge of 503b compounding regulations and FDA guidelines.
  • Analytical Skills: Strong analytical skills and attention to detail.
  • Communication and Leadership: Excellent communication and leadership abilities.
  • Quality Improvement: Proven track record of successfully managing audits and implementing quality improvement initiatives.