Job Summary of the Director, Quality Assurance

The Director, Quality Assurance will be a key member of the AxoGen Leadership team with responsibility for establishing and administering all Quality functions related to cGXX (cGMP, QSR and cGTP) operations. The Director, Quality Assurance will provide quality oversight and support AxoGen’s manufacturing, processing, testing and product distribution functions. The position requires domestic and international travel, primarily to AxoGen locations to ensure compliance with domestic and international regulations.  

Requirements of the Director, Quality Assurance

• BA, MS or PhD with at least 10 years’ experience in a quality assurance or related role in the biologics or pharmaceutical industry is required
• Demonstrated knowledge of cGXXs and relevant regulatory guidelines in the US and OUS.
• Familiarity with ISO 13485 requirements for the design and manufacture of medical devices.
• Experience at all phases of development, including commercialization.
• Experience in leading external regulatory audits
• Demonstrate experience in successful hiring and management of a quality or related organization/group. 
• Excellent oral and written communication skills 
• Excellent interpersonal and team-building skills
• Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive information and problem solve
• Ability to exercise creativity and judgment 
• Experience with human tissue products or implantable medical devices is desirable 
• Experience with quality functions for biologics is required
• Experience with Six Sigma and/or Lean Manufacturing desirable complex
• Familiar with preparation of and guidelines for Chemistry, Manufacturing, and Controls (Module 3) worldwide regulatory submissions desirable.  

Responsibilities of the Director, Quality Assurance

The specific duties of the Director, Quality Assurance include but are not limited to:

• Establishes and administers AxoGen’s Quality Management System
• Oversees all quality functions related to human tissue products, biologic products and medical devices.
• Ensures compliance with relevant domestic and international quality requirements
• Provides guidance on and administer process validation activities
• Performs risk assessments and leads investigations to address quality issues
• Performs release and disposition functions; manages and controls cGXX-manufactured intermediates and products; works with AxoGen Operations, Clinical and Translation Science staff as required 
• Represents AxoGen during external audits and inspections and ensures pre-approval inspection readiness 
• Participates in vendor selection, assessment and qualification 
• Works with internal and external technical teams (process, analytical, formulation development, quality control)
• Recruits, develops, and manages the Quality Assurance department as the company’s pipeline and development activities grow 
• Develops budget for Quality Assurance department 
• Axogen is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities. 
• As a key and senior member of the Axogen Leadership team, the Director is expected to participate in operational and strategic discussions that impact the entire organization.
• Other duties as assigned  Experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others.  

Location

913 Industrial Drive Place, Vandalia, OH  45377

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Benefits/Compensation