QA Manager opening at a biotechnology company focused on spearheading breakthroughs in regenerative medicine using adult, autologous Mesenchymal Stem Cells.
QA Manager
Schedule: M-F Onsite, 8-5pm, (flexible to 8:30-530 or 9-6 if needed)
Pay: $80-95k
2 direct reports: QA associates
- Provide comprehensive quality oversight and guidance throughout the end-to-end manufacturing process of cell therapy products for individual use or for clinical trials.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 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.
- Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites.
Education/ Experience:
· 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. (1-2 years in a lead or supervisory role- does not have to be within QA but preferred).
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!