Position Summary

The Vice President, Quality Assurance will serve as an in-house subject matter expert on GxP compliance. He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and Exela on all quality and compliance topics.

Job Responsibilities 

• Design and implement programs, policies, and practices to ensure Quality Assurance and GxP compliance, and lead a quality culture within the organization.
• Ensure quality organizational processes conform with standard operating procedures.
• Manage strategy and approach for all inspection/ audits in compliance with local and global regulatory agencies.
• Respond to requests from regulatory agencies. Leads in the creation of reports and documentation needed for regulators.
• Actively scans regulatory landscape to ensure alignment and identify laws and
   regulations that impact the company’s policies. Develop appropriate change and communication approach as needed.
• Manage changes in systems or procedures when necessary. Develop appropriate change and communication approach as needed.
• Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
• Responsible for OOS, deviations, and product complaint investigations and GxP archives
• Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance
• Oversee compliance auditing program to fulfill regulatory requirements.
• Follow applicable regulations, including FDA, ICH, and GxP
• Effectively manage the departments of Quality Assurance, Sterility Assurance, and Quality Control.

Experience Requirements

• 15 years of relevant and current work experience in pharmaceutical / biotech / CDMO industry Quality Assurance and Regulatory Affairs required
• 10 years of progressive people leadership and workforce engagement.
• Experience in leading and managing regulatory inspections for commercial manufacturing licensure.

Education Requirements 

Bachelor’s degree or higher, with a focus in Engineering, Life sciences, or other similar technical field