Senior Manager, Quality Assurance

Pleasanton, CA
Posted 9 months ago

Responsibilities:

  • Implements and maintains programs and processes to ensure high-quality products and compliance with cGMP and GLP.
  • Primary areas of responsibility include QMS maintenance, Document Control and Document Changes, Trending, Production and R&D Internal Audits, Supplier Qualification and Complaints.
  • Contributes to Training, DMR maintenance, tech transfer, batch disposition, labelling approval, deviation and NCR investigations, product and process changes and CMO oversight.
  • Reviews manufacturing and equipment logs, and quality control data for in-process and finished products
  • Supports inspection management and interacts closely with regulatory agencies.
  • Oversees establishment of product specifications., writes and updates SOPs.
  • Works extensively with cross-functional teams.
  • May lead on investigations of deviations, nonconformances and complaints

Qualifications:

  • Bachelor of Science degree with 5+ years’ experience in Quality Assurance
  • Knowledge of ISO 13485:2016, 14971:2012 and 21CFR 820.
  • Excellent communication, documentation, and organizational skills
  • A commitment to continual improvement
  • Demonstrates knowledge of MS Office software
  • Must have the ability to work effectively under high pressure with multiple deadlines

 

Job Features

Job CategoryQA/RA

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