Senior Quality Program Lead, GMP & Cell Therapy

Socket.dev; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurona Therapeutics in South San Francisco is seeking a Senior Manager, Quality Program Management to own the integrated quality plan across QA and Quality Systems. You will coordinate milestones, risks, and governance with cross-functional partners and lead harmonization efforts for GMP and ISO compliance.

In this fast-paced biotech environment, you will drive BLA readiness activities, track progress against milestones, and mentor team members while ensuring state-of-control quality operations

Qualifications

• 8+ years of Quality experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred).
• Experience supporting a product launch or BLA/commercial transition strongly preferred.
• Strong foundation in Clinical Supply Process or equivalent pharma/healthcare supply chain process.
• Project Management Certification preferred.
• Excellent organizational skills with the ability to manage multiple priorities under GMP timelines.
• In-depth knowledge of cGMP.
• Proficient with MS Office and ability to learn new software.

Responsibilities

• Lead and coordinate quality-related partnership activities across Quality, Operations, Regulatory, Supply Chain, and other functions.
• Develop and maintain an integrated Quality Plan with milestones, deliverables, dependencies, risks, owners, and timelines.
• Establish program governance with recurring meetings, status reports, action logs, and executive updates.
• Coordinate migration and harmonization of quality management systems and documentation.
• Identify differences and facilitate decisions on future-state processes with Quality leaders.
• Support development and implementation of future-state quality processes and operating models.
• Maintain inventory of quality systems, procedures, records, metrics, tools, and critical quality infrastructure.
• Identify quality risks, develop mitigation plans, and elevate issues impacting compliance or product quality.
• Track progress against milestones and communicate risks and opportunities for improvement.
• Facilitate cross-functional sessions to resolve gaps and align responsibilities.

Skills

Quality management

GMP knowledge

Project management

Regulatory compliance

Cross-functional leadership

Data interpretation

Change management

Audits

MS Office

Education

BA/BS in Microbiology, Biology, Chemistry, Engineering or related field

Tools

MS Office

Job description

Neurona Therapeutics in South San Francisco is seeking a Senior Manager, Quality Program Management to own the integrated quality plan across QA and Quality Systems. You will coordinate milestones, risks, and governance with cross-functional partners and lead harmonization efforts for GMP and ISO compliance.

In this fast-paced biotech environment, you will drive BLA readiness activities, track progress against milestones, and mentor team members while ensuring state-of-control quality operations