Director, Quality Assurance

Director, Quality Assurance

Responsible for developing and administering Quality System and ensuring product meets the established standards of quality. This position will be the Management Representative for Management Review.  Reports to Chief Quality Officer.

Main Job Tasks and Responsibilities

  • Develop high performing Quality Assurance team
  • Partner with R&D and Manufacturing to foster a collaborative and exciting work environment to bring innovative new products to patients
  • 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, ISO 13485 audits
  • 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 perspective

Education and Experience

  • Bachelor’s degree in life science or engineering
  • Advanced degree preferred
  • 5+ years of experience in Quality Assurance in pharma, biologics, or Class 3 medical devices
  • Experience with implementation of Quality system for startup company preferred
  • ISO 13485 and GMP knowledge and experience
  • Strong computer skills including Microsoft Office and databases
  • Knowledge of tools, concepts and methodologies of QA
  • Familiar with FDA regulations in Biologics and Blood products preferred

Key Competencies

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