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Manufacturing Quality Manager

3 months ago

Novato, United States Tucker Parker Smith Group (TPS Group) Full time

Technical Manager/QA

Location: Novato, CA (Hybrid 3 Days on Site)

Assignment:12 months (Great potential to extend or convert)

Pay Rate: $60.40/hr.


Our client is a leading global pharmaceutical company specializing in therapeutics for rare and life-threatening genetic diseases. They are committed to advancing patient care through innovation and excellence in quality. The Technical Manager/QA will play a crucial role in representing the Quality Department, ensuring robust oversight of the company’s Quality Systems.


Responsibilities:

  • Ensure consistent administration and adherence to Quality Systems, including Documentation, Deviation, CAPA, Change Control, Self-Inspection, and Risk Management.
  • Participate in inspection readiness and provide support during regulatory inspections and self-inspections.
  • Monitor quality system metrics and trends to drive continuous improvement initiatives.
  • Collaborate cross-functionally with Technical Operations and other departments to maintain alignment in quality system implementation.
  • Lead initiatives for quality system enhancement and process mapping.
  • Develop and maintain site-specific Quality Technical Agreements.


Education and Experience:

  • BS/MS in life sciences or related field.
  • 6 +years of experience in the pharmaceutical or related industry.
  • In-depth understanding of cGMPs, Health Authority Regulations, and Quality Systems.
  • Technical proficiency in manufacturing processes and ability to interpret analytical data.
  • Familiarity with FDA, EMA, and international regulatory requirements.