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Job Details

Quality Director
Oakwood, OH  Posted: 10/21/2020


A Specialty Pharmaceutical Company has an exciting opportunity for a Quality Director! 
Essential Job Functions Include:
  • Develop, implement, and oversee quality activities for the manufacturing site
  • Develop or update quality systems and processes to ensure compliance with current regulatory requirements and expectations
  • Maintain current regulatory requirements, guidance documents, and emerging industry trends to support the company’s objectives and enhance the efficiency and quality of manufacturing operations
  • Support interdepartmental teams in taking products from development, through manufacturing, clinical trials, regulatory approval, and commercialization
  • Support the introduction and transfer of contract customer products and products into the manufacturing facility. Interface directly with contract customer representatives and R&D to support Quality related activities
  • Ensure the site incorporates a risk-based approach into the development and enhancements of quality systems and that the risk management approaches are aligned and/or developed to comply with current GMP regulations and industry expectations
Desired skills and experience include:
  • Ten+ years working in an ISO certified or FDA regulated manufacturing environment that includes qualification, validation, and testing procedures
  • Demonstrated working knowledge of a cGMP environment
  • Prior experience managing and developing a team
  • Pharmaceutical manufacturing experience preferred
  • Prior quality support in a sterile filling function is a plus
  • Knowledge of 21 CFR Part 11 is a plus
  • B.S. in a science related discipline or equivalent work experience
  • Ability to use Microsoft Word, Excel, PowerPoint, and electronic quality/document management

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