Biotechnology Quality Assurance Director
4 weeks ago
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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