Director/Senior Director of Quality Operations Location: On-Site - South San Francisco The Director/Senior Director of Quality Operations will provide leadership and direct quality oversight of Manufacturing, Quality Control (QC), and Supply Chain activities for Neurona. This role ensures GMP compliance across day-to-day operations through effective quality risk management, supports efficient and reliable manufacturing execution to ensure the safety, efficacy, and quality of cell therapy products, and maintains inspection readiness. The position partners closely with Manufacturing, QC, Operations, and Supply Chain teams to enable compliant, risk-based decision making, timely product disposition, and continuous improvement while maintaining patient safety and product quality.
Responsibilities:
- Provide Quality Assurance oversight of GMP Manufacturing, QC testing, Operations, and Supply Chain operations through the product lifecycle.
- Apply Quality Risk Management principles to support Manufacturing, QC, Operations, and Supply Chain operations.
- Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
- Ensure quality risk decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.
- Partner with Manufacturing, QC, Operations, and Supply Chain to resolve quality issues arising during manufacturing, laboratory activities and material receipt and shipping.
- Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely product disposition.
- Evaluate operational and quality risks related to new product introduction.
- Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, Operations, and Warehouse areas to support continuous improvement.
- Serve as a key Quality contact during regulatory inspections and internal audits, including preparation and response to findings.
- Monitor regulatory requirements and proactively assess potential operational compliance risks.
- Approve GMP documentation including procedures, master batch records, specifications, and analytical methods.
- Ensure effective document and record control practices across Manufacturing, QC, Operations, and Supply Chain functions.
- Drive continuous improvement of quality processes supporting GMP operations.
- Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
- Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, Operations, and Quality management.
- Lead or support Quality-related operational projects and improvement initiatives.
- Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
- Use risk-based decision making to prioritize tasks and ensure product quality.
- Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.
- Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations.
- Provide and deliver ongoing training for GMP, GDDP, and Data Integrity.
- Identify and support resolution of technical problems.
- 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.
- Ensure good working relationships with the site management and all other departments.
- 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.
Required Qualifications:
- Minimum of 10 years of Quality experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred).
- Extensive hands-on experience supporting GMP Manufacturing and QC operations is required.
- Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP, ICH, FDA , etc.).
- Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines.
- Proven experience leading batch disposition, investigations, CAPA, and change management in a GMP operational environment is required.
- Experience supporting Health Canada, FDA, or other regulatory inspections would be beneficial.
- Strong understanding and experience of materials management, manufacturing and analytical testing systems within a GMP environment.
- Previous experience in people management is essential.
- Strong leadership, mentoring, and team-building abilities.
- Exceptional technical writing, data analysis, and problem-solving skills.
- Effective communicator, capable of interacting with cross-functional teams and external auditors.
- Comfortable in a fast-paced, dynamic environment supporting clinical and commercial manufacturing.
- Adhere to cGMP policies and procedures, including documentation activities
- Able to wear appropriate personal protective equipment
- Able to work collaboratively to respond to changing priorities and challenges
- Communicate effectively with team members and contribute to a positive and collaborative work environment
- Actively participate in group and project teamwork, project and process improvements
Education Requirements:
- BA/BS degree in Microbiology, Biology, Chemistry, or related field and at least 10 years of Quality experience in a GMP-regulated environment.
