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Director Quality Operations

4 months ago

Cambridge, United States EPM Scientific Full time

Quality Operations Director



Key Responsibilities:

  • Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.
  • Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.
  • Maintain and oversee a robust quality management system.
  • Collaborate effectively with cross-functional teams to ensure seamless product launches.
  • Proactively identify, assess, and mitigate quality risks.
  • Oversee the Quality Operations department, including 11 direct reports



Qualifications:

  • Bachelor's degree in a relevant field, with a minimum of 14 years of experience (10+ years in Quality, 8+ years managing quality personnel). Alternatively, a Master's degree with a minimum of 12 years of experience (10+ years in Quality, 8+ years managing quality personnel) is acceptable. Prior leadership experience is essential.
  • In-depth understanding of regulatory requirements for the biopharmaceutical and/or medical device industry.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to lead and develop a high-performing team.



Preferred Qualifications:

  • Prior experience in the medical device or biotechnology industry (biologics)
  • Internal and external quality audit oversight