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
Seniority level
Executive
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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