Director/Senior Director of Quality Assurance – Medical Device

About the role

Director/Senior Director of Quality Assurance - Medical Device Location: On-Site - South San Francisco Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Neurona Therapeutics is seeking an exceptional candidate to join our Quality Assurance (QA) team. Our ideal candidate is a self-motivated individual who has a passion for QA and can thrive in a fast-paced dynamic environment. The Director/Senior Director of Quality Assurance – Medical Device directs and coordinates all quality assurance activities related to the device portion of a combination product. All candidates should have progressive leadership experience with developing quality systems, audit, and device verification. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with 21 CFR 4 and the relevant part of Medical Device (21CFR 820s), ISO 13485, and ISO 14971-2 and other worldwide regulations related to combination products. Specific areas of responsibility include, but are not limited to, design and oversee the Quality Systems related to oversight of the medical devices used in the delivery of the cell therapy to patients. This includes vendor audits, use-related risk assessments, oversight device verification, etc. This position interacts cross-functionally with the Cell Delivery, Translational Medicine, Operations, Regulatory, and Quality Assurance groups to ensure that all device areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.

Responsibilities

• Responsible for developing, reviewing and maintaining the quality systems related to the device of the combination product
• Manage and oversee corrective action teams and develop individual corrective action plans and systems
• Direct, manage, and oversee the activities of quality staff and personnel performing verification activities
• Prioritize quality engineering projects and assignments for completion by the appropriate QA personnel
• Responsible for the performance management and career development of direct reports and their subordinates.
• Analyze internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards
• Responsible for the investigation of product and process quality and manufacturing issues
• Perform periodic complaint trend analysis, make recommendations, and review associated action plans for complaint reduction
• Keep the leadership teams informed about quality-related problems and issues related to the device
• Participate in audits and prepare appropriate corrective action responses
• Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and followed
• Build and maintain strong working relationships with site management and cross-functional departments, as well as external customers and regulatory agencies
• Generate quality plans, control plans, procedures, work instruction for overall quality and coordinate on effective implementation of such plans, procedures or instructions in compliance of regulatory requirements such as FDA, etc
• Maintain high-quality-assurance design services, engineering and manufacturing programs, standards and improvements within the organization
• Support Commercial team with customer interfaces where necessary on quality related issues, including quality escalation issues
• Serve as Device Quality SME during audits and regulatory inspections.
• Perform other duties as requested by supervisor/manager to support Quality.
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
• Manage operational performance using key performance indicators.
• Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures.

Qualifications

• Bachelor’s degree, preferably in engineering or technical discipline
• ASC CQE certification, preferred
• 10+ years’ experience in engineering with progressive and extensive experience in medical device quality assurance