Careers

Director, Quality Assurance and Regulatory Affairs

Director, Quality Assurance and Regulatory Affairs

Responsible for developing and administering Quality System and ensuring product meets the established standards of quality. Responsible for Regulatory Affairs and compliance to regulatory standards, FDA, EU, etc for company. Reports to Chief Quality Officer

Main Job Tasks and Responsibilities:

  • Draft quality assurance policies and procedures
  • Responsible for document management system
  • Interpret and implement quality assurance standards
  • Develop, recommend and monitor corrective and preventive actions
  • Develop and manage Supplier Quality program
  • Evaluate adequacy of quality assurance standards
  • Devise sampling procedures and directions for recording and reporting quality data
  • Plan, conduct and monitor testing and inspection of materials and finished products
  • Document internal audits and other quality assurance activities
  • Analyze data to identify areas for improvement in the quality system
  • Prepare reports to communicate outcomes of quality activities
  • Identify training needs and ensure cGMP training for all employees
  • Coordinate and host audits, FDA inspections
  • Assure ongoing compliance with quality and industry regulatory requirements
  • Understand and stay up to date with current FDA and EU regulatory requirements, guidances that pertain to company products.
  • Develop and write documents for regulatory submission, IND, BLA, technical dossier.
  • Support product development needs from QA/RA perspective

Education and Experience:

  • Bachelors degree in life science or engineering
  • Experience with implementation of Quality system for startup company preferred
  • Regulatory Affairs experience
  • Regulatory Compliance experience
  • Experience with Quality System development in pharma, biologics, or Class 3 devices
  • Strong computer skills including Microsoft Office and databases
  • Knowledge of tools, concepts and methodologies of QA
  • Knowledge of FDA regulations in Biologics and Blood products preferred

Key Competencies:

  • Attention to detail
  • Communication skills - verbal and written
  • Ability to work independently
  • Planning and Organizing
  • Data collection, management and analysis
  • Problem analysis and problem solving
  • Partnering and teamwork
  • Decision-making