Position: Associate Director, Quality Assurance
Location: Chandler, Arizona (onsite)
Company: Medivant Healthcare
Position Overview:
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:
- To ensure implementation and maintenance of current Good Manufacturing Practice (cGMP) standards and all applicable international quality standards in the plant.
- To ensure that the product meets the defined standards for strengths, identity, safety, purity, and quality by various system-driven approaches.
- To review corrective and preventive actions in line with root cause analysis for complaints and non-conformities to minimize chances of such re-occurrences.
- To review and approve documents like Site Master file, Validation Master Plan, Standard Operating procedures, Master Batch Document and Validation Protocols before implementation.
- To review and Execute Validation Activity and give suggestions for enhancement or improvement in line with the current regulatory expectations, if required.
- To guide and suggest any changes to various departments during SOP review to upgrade and improve quality management systems, in line with current regulatory expectations.
- To ensure review and approve 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.
- To ensure the implementation of Internal Quality Audit (IQA) schedule for manufacturing facilities of the company.
- To ensure and sustain all time audit ready plant in line with current regulatory expectations for regulatory authorities and other partner inspections.
- To 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:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field; advanced degree or certification (e.g., CQE) preferred.
- Minimum of 5 years of experience in quality assurance, with at least 2 years in a managerial role within a compounding or pharmaceutical environment.
- In-depth knowledge of 503b compounding regulations and FDA guidelines.
- Strong analytical skills and attention to detail.
- Excellent communication and leadership abilities.
- Proven track record of successfully managing audits and implementing quality improvement initiatives.
