Director of Quality Operations

2 weeks ago


Fremont, California, United States Jobleads-US Full time

Job Description

The Associate Director, QA will lead the Quality Assurance team, responsible for implementing quality management systems and ensuring compliance with regulatory requirements. This role will oversee data integrity, eQMS records, and quality process trends.

Responsibilities

  • Oversee Quality Assurance Operations and Systems group to execute on quality processes for commercial and clinical products manufacturing, testing, and design development.
  • Manage materials and product lot release for clinical and commercial products, ensuring data integrity compliance with internal and external executed data and records.
  • Track and trend quality process data, leading discussions on trending analysis of key quality indicators and/or key process indicators.
  • Lead cross-functional teams in data collection and evaluation of commercial products and deliver product quality review reports annually.
  • Chair Quality Review and Material Review Board meetings as needed.

Requirements

  • Bachelor's degree in a scientific or related field.
  • Minimum 10+ years cGMP experience in Quality Assurance.
  • Knowledge and understanding of combination pharmaceutical/device product 21 CFR 3.
  • Familiarity with electronic Quality Management Systems (e.g., Veeva, Trackwise).
  • Experience in Quality Systems, Validation, and/or risk Management in the medical device, pharmaceutical, biologics, or combination products industry.
  • Proficient in MS Office, Excel, database management systems, project management software, ERP software, and Quality Systems software.
  • Ability to make tough decisions and influence project deadlines and quality outcomes.


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