Senior Quality Program Lead — GMP Strategy

Neurona Therapeutics; South San Francisco (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Neurona Therapeutics in South San Francisco, CA is seeking a Senior Manager, Quality Program Management to lead the integrated quality plan across QA and Quality Systems. This role partners with cross‑functional teams to ensure state of control and compliance with GMP/ISO standards.

The ideal candidate will have 8+ years in GMP‑regulated quality, strong project management, and ability to drive harmonization of systems, with a track record of launching or transitioning products.

Qualifications

• Eight+ years of quality experience in a GMP‑regulated environment (cell therapy, biologics, or sterile pharma preferred).
• Experience supporting product launches or BLA/commercial transitions is strongly preferred.
• Strong foundation in Clinical Supply or pharma/healthcare supply chain processes.
• PM certification is preferred.
• Excellent organizational skills with ability to manage multiple priorities under GMP timelines.
• In‑depth knowledge of cGMP and regulatory requirements.

Responsibilities

• Lead and coordinate quality-related partnership activities across Quality, Operations, Engineering, Regulatory, and Supply Chain.
• Develop and maintain an integrated Quality Plan with milestones, deliverables, risks, and owners.
• Establish governance with meetings, status reports, action-item tracking, and executive updates.
• Coordinate migration and harmonization of quality management systems and documentation.
• Identify process gaps and drive decisions on future-state processes with stakeholders.
• Monitor quality metrics, KPIs, dashboards, and reporting mechanisms.
• Ensure activities comply with GMP/ISO, internal procedures, and company policies.
• Develop and maintain training plans for impacted employees.

Skills

Quality management

Project management

GMP

cGMP

Regulatory knowledge

Cross-functional leadership

Data analysis

MS Office

Education

BA/BS in Microbiology/ Biology/ Chemistry/ Engineering

Tools

MS Office

Job description

Neurona Therapeutics in South San Francisco, CA is seeking a Senior Manager, Quality Program Management to lead the integrated quality plan across QA and Quality Systems. This role partners with cross‑functional teams to ensure state of control and compliance with GMP/ISO standards.

The ideal candidate will have 8+ years in GMP‑regulated quality, strong project management, and ability to drive harmonization of systems, with a track record of launching or transitioning products.