Quality Assurance Director

6 days ago


Seattle, Washington, United States BioTalent Full time
Quality Assurance Manager

The Quality Assurance Manager will provide strategic leadership to the Quality Systems team, ensuring the effectiveness of the Seattle Operations site Quality Management System. This role will manage cross-functional teams, drive standardization and alignment, and support the release of high-quality products.

Key Responsibilities
  • Team Leadership: Manage the Quality System Specialist team, developing and implementing development plans to drive growth and success.
  • Quality System Improvement: Launch and support global initiatives to improve the overall efficiency of the Quality Management System.
  • Quality Review: Conduct thorough quality reviews of documentation to ensure compliance and support the release of high-quality products.
  • Action Item Management: Maintain the integrity of the Quality Management System by following up on action items and driving completion.
  • Audit Support: Support internal and external audits by representing quality documentation and responding to findings in a timely manner.
Requirements
  • Education: Bachelor's degree or equivalent in a related field required.
  • Experience: 5+ years' relevant quality systems experience with supervisory experience, or equivalent combination of education and experience.
  • Skills: Ability to work well in fast-paced and cross-functional teams, working knowledge of the device/drug/biotech manufacturing process, experience with risk management regulations and application, and understanding of working in a regulated environment 21 CFR 820 and ISO 13485 and 14971 standards.


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