Director of Quality
JOB DESCRIPTION

Personal Genome Diagnostics (PGDx) is Empowering the Fight Against Cancer by unlocking actionable information from the genome. We are developing an innovative portfolio of regulated tissue-based and non-invasive liquid biopsy genomic products for laboratories worldwide.  We are seeking a highly motivated Director of Quality to join our team.  

KEY RESPONSIBILITIES
  • Provide leadership and direction on IVD design and development related activities/issue and act as Quality Assurance SME for PGDx development teams and colleagues
  • Build and establish a team of a team of Quality experts to effectively support PGDx product development, on market support and CLIA services
  • Develop strong relationships with PGDx personnel across functions and teams providing quality guidance as needed
  • Guide Quality involvement in IVD product development, CAPA and process improvement teams
  • Manage internal and external audits of the IVD quality system
  • Maintain expertise in ISO 13485:2016, ISO 14189, and FDA standards that may impact IVD product development
  • Serve as Quality Management Representative as required by standards such as ISO 13485
  • Provide regular updates to senior management functions and participate in the resolution of quality issues 
  • Manage inspection readiness program and make recommendations for continuous improvement
  • Lead quality and compliance initiatives

 

REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s degree in biology or related area; advanced degree strongly preferred
  • A minimum of 7+ years’ experience in diagnostics development and quality assurance
  • Able to take leadership role and manage a growing team
ABOUT PERSONAL GENOME DIAGNOSTICS

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@personalgenome.com Special consideration will be given to internal PGDx employees who apply.

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