Director, QA

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Scope of Function: Responsible for overseeing the Quality Assurance and Documentation Control. Assure quality systems and standard operating procedures are in compliance with appropriate regulations such as cGMP regulations
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Specific Duties:

• Guide Quality Assurance personnel activities
• Develop and implement Quality Management system, departmental policies and procedures and provide support and guidance to the daily operations of facilities and controls
• Appraise management of quality issues and work with them to resolves them
• Write and/or revise SOPs and Quality System Manual
• Ensure materials are handled in cGMP compliant manner
• Coordinate/perform Internal and External Audits
• Participate in client and regulatory agency audit/inspections
• Investigate root cause for failures, noncompliance, customer complaints and implement corrective and preventive action (CAPA)
• Conduct/assist/organize company-wide annual training in GMP/GDP compliance
• Attend production meetings and other meetings as required
• Prepare CMC sections of regulatory submission documents including IND and BLA
• Experience with commercial manufacturing of approved biologics is required

Education, Experience and Skills Required:

Education:

• Bachelor’s degree in Life Sciences or a related scientific field

Experience:

• Minimum of seven years experience working in an FDA regulated environment for manufacturing of Biopharmaceuticals and Biologics
  
• Commercial manufacturing of approved biologics is required

Skills:

• Experience and proficiency in technical writing are also required

​Interacts With: 

• Quality Control, cGMP Manufacturing, Project Management, Clients, Consultants and the Food and Drug Administration