Biotechnology Quality Assurance Director

4 weeks ago


Houston, Texas, United States Astrix Full time

Biotechnology Quality Assurance Director

Astrix is seeking a Biotechnology Quality Assurance Director to spearhead quality oversight and guidance throughout the end-to-end manufacturing process of cell therapy products for individual use or for clinical trials.

Key Responsibilities:

  • Provide comprehensive quality oversight and guidance throughout the manufacturing process.
  • Ensure that our Mesenchymal Stem cell products meet the highest standards of quality and reliability.
  • Oversee the life cycle from starting materials until Finished Goods manufacturing.
  • Ensure compliance with regulations, contributing to the development of the quality management system, and providing innovative quality input and support to the company.
  • Be an expert in quality management system, ensuring activities conform with requirements.
  • Be a subject matter expert on investigations, deviations, root cause analysis tools, CAPAs, change control, and complaint investigations.
  • Support and participate in compliance audits, OSHA inspections, and interactions with regulatory agencies.
  • Identify compliance gaps, quality issues/discrepancies, and effectively and proactively resolve them in a flexible and constructive manner.
  • Corrective and preventative actions (CAPA) - Implementation and Evaluating the adequacy and effectiveness of corrective and preventive action plans.
  • Deviation & out of specification (OOS) reporting.
  • Complaint and recall handling.
  • Calibration and maintenance coordination.
  • Qualification & validation coordination.
  • Internal and external audits including vendor /supplier qualification.

Requirements:

· Possess a Bachelor's degree in life sciences AND a minimum of 7 years of relevant experience in the biotechnology, pharmaceutical or biological sciences industry OR Master's degree with 4 years of experience.

· Have at least 2 years of demonstrated experience in Quality Assurance operations, preferably in a management role.

Astrix is an equal opportunity employer and welcomes applications from diverse candidates.



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