Kyle Adams

Serve as Quality representative supporting U.S. pharmaceutical operations and distribution activities.

• Ensure compliance with global QMS requirements and U.S. regulatory standards, including GDP and GSP expectations for pharmaceutical storage and distribution.
• Partner with Regulatory Affairs and 3PL providers to maintain quality oversight across warehousing, transportation, and distribution operations.
• Manage quality events including deviations, product complaints, investigations, and CAPAs, ensuring timely resolution and risk mitigation.
• Support FDA inspection readiness activities, including documentation preparation, audit coordination, and response tracking.
• Monitor supply chain quality risks and implement corrective and preventive actions to minimize compliance exposure.
• Lead quality metrics trending and management review reporting, identifying recurring issues and improvement opportunities.
• Maintain compliant documentation and oversee SOP lifecycle management aligned with global standards.

Led Quality Assurance oversight of external vendors and CDMOs supporting U.S. supply chain and commercial manufacturing activities.

• Served as primary QA liaison for external partners, ensuring alignment with corporate QMS and regulatory expectations.
• Oversaw supplier quality management, audits, and performance monitoring, including 3PL and distribution partners.
• Managed investigations, deviations, CAPAs, and change controls impacting supply chain and product distribution.
• Supported regulatory inspections and vendor audits to ensure sustained inspection readiness.
• Developed quality dashboards and performance metrics to assess compliance trends across external partners.
• Assisted in maintaining and updating Quality Agreements to clarify roles, responsibilities, and compliance expectations.

Provided Quality oversight for CMO manufacturing and supply chain activities.

• Reviewed and approved CMO-submitted change controls and deviations affecting distribution and product release.
• Supported quality risk assessments for supply chain and product transfer activities.
• Partnered with Regulatory Affairs and Technical Operations to ensure compliance with FDA and global regulatory requirements.
• Contributed to audit readiness and regulatory inspection support efforts.

Supported GMP quality systems across manufacturing and supply operations.

• Managed deviations, investigations, CAPAs, and complaints related to manufacturing and distribution activities.
• Conducted internal audits and supported external regulatory inspections.
• Maintained quality documentation and ensured adherence to corporate and regulatory standards.
• Collaborated cross-functionally to strengthen compliance and improve quality processes.