Associate Director, QA Audits
A company is looking for an Associate Director, QA Audits & Inspections Program. Key Responsibilities Champion and adhere to the Quality Management System (QMS) and assist in crafting QA organizational goals Mentor a team of Quality professionals, ensuring compliance with regulations and timely quality deliverables Oversee internal and external QA audits, manage Sponsor audits, and participate in regulatory inspections Required Qualifications Bachelor's degree in nursing, biological, physical, health, pharmacy, or related science 8+ years of relevant GCP experience or equivalent work experience Experience in conducting various types of QA audits, including Clinical Investigator and Vendor Audits Previous participation in regulatory inspections (e.g., FDA, MHRA, Health Canada) Broad understanding of quality and regulatory compliance related to GxP activities, specifically GCP knowledge
A company is looking for an Associate Director, QA Audits & Inspections Program.
Key Responsibilities
Champion and adhere to the Quality Management System (QMS) and assist in crafting QA organizational goals
Mentor a team of Quality professionals, ensuring compliance with regulations and timely quality deliverables
Oversee internal and external QA audits, manage Sponsor audits, and participate in regulatory inspections
Required Qualifications
Bachelor's degree in nursing, biological, physical, health, pharmacy, or related science
8+ years of relevant GCP experience or equivalent work experience
Experience in conducting various types of QA audits, including Clinical Investigator and Vendor Audits
Previous participation in regulatory inspections (e.g., FDA, MHRA, Health Canada)
Broad understanding of quality and regulatory compliance related to GxP activities, specifically GCP knowledge
