Senior Manager, Quality Program Management

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

We are hiring! Our ideal candidates are self-motivated individuals who have clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and build an exciting, science-driven company. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Position:Senior Manager, Quality Program Management

Location: South San Francisco, CA

Job Id:373

# of Openings:1

Senior Manager, Quality Program Management

Reports to: VP, Quality

Work Type: On-site

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.

This role owns the integrated project plan across the Quality Organization’s ongoing initiatives, consolidating and coordinating projects led by the Quality Assurance and Quality Systems teams so those teams can focus on execution. All candidates should have leadership and project management experience. Activities will include developing and maintaining an integrated quality plan that encompasses the multiple workstreams within quality.

Specific areas of responsibility include, but are not limited to, supporting project management activities related to harmonization of quality systems, upgrade of quality systems, and BLA readiness activities. The Sr. Manager, Quality Program Management will ensure that the overarching plan for all quality-related activities exists and attend project related meetings on behalf of the quality team. This position interacts cross-functionally with both Neurona and UCB personnel to ensure that all quality plans are maintained to ensure a state of control in accordance with applicable regulatory and compliance guidelines.

Responsibilities:

• Lead and coordinate quality-related partnership activities, ensuring alignment across Quality, Operations, Engineering, Regulatory, Supply Chain, and other key functions.
• Develop and maintain an integrated Quality Plan, including milestones, deliverables, dependencies, risks, owners, and timelines.
• Establish program governance, including recurring meetings, status reporting, action-item tracking, decision logs, escalation processes, and executive-level updates.
• Coordinate the migration and harmonization of quality management systems, processes, procedures, standards, and documentation.
• Partner with Quality leaders and subject matter experts to identify differences and facilitate decisions on future-state processes.
• Support the development and implementation of future-state quality processes and operating models, ensuring appropriate ownership, accountability, and transition plans.
• Maintain a comprehensive inventory of quality systems, procedures, records, metrics, tools, and other critical quality infrastructure impacted by the partnership.
• Identify partnership-related quality risks, develop mitigation plans, and proactively elevate issues that may impact compliance, product quality, customers, or business continuity.
• Track and communicate progress against key milestones, identifying schedule risks, resource constraints, dependencies, and opportunities for improvement.
• Facilitate and participate in cross-functional working sessions to resolve process gaps, clarify responsibilities, and drive alignment between the two organizations.
• Support the assessment and development of quality metrics, KPIs, dashboards, and reporting mechanisms, helping establish consistent definitions and reporting practices.
• Ensure quality plan activities are executed in accordance with applicable quality standards, regulatory requirements, internal procedures, and company policies.
• Develop and maintain partnership-related training plans and coordinate training activities to ensure impacted employees understand new processes, systems, roles, and responsibilities.
• Serve as a central point of coordination for the Quality organization, ensuring timely communication of partnership updates, decisions, risks, and changes.
• Create and maintain program-level documentation, including project plans, risk registers, action logs, meeting materials, process maps, decision records, and status reports.
• Identify opportunities to simplify, standardize, and improve quality processes as part of the partnership rather than simply replicating legacy practices.
• Support change‑management activities within the Quality organization, helping teams understand the rationale, impact, timing, and expectations associated with organizational and process changes.
• Partner with leadership to establish clear quality priorities, ensuring continuity of critical quality operations throughout the partnership.
• Coordinate activities to verify that transitioned processes are functioning as intended and that outstanding gaps and risks are appropriately addressed.
• Develop lessons learned and continuous‑improvement recommendations to strengthen future activities and overall Quality program effectiveness.
• 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
• Liaise with Neurona and UCB cross‑functional teams
• Build and maintain strong working relationships with site management and cross‑functional departments, as well as external customers and regulatory agencies
• Perform other duties as requested by supervisor/manager to support Quality.
• Work collaboratively with cross‑functional teams 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.
• Begin engagement with the Commercial team’s ongoing quality‑related projects, with the expectation of expanding coverage to additional teams over time.

Required Qualifications:

• Minimum of 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 the 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‑dept knowledge of cGMP
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
• Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience
• Ability to work in a fast‑paced team environment and lead peers through changing priorities
• Proven ability to negotiate and resolve differing perspectives among stakeholders to reach mutually beneficial solutions.
• Ability to motivate and foster a positive team environment
• Ability to think strategically with an enterprise mindset, establishing deadlines and prioritizing work accordingly to business needs and budget.
• Exhibit strong decision‑making ability and analytical thinking while maintaining compliance and quality.
• Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions.
• Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders.
• Ability to lead change in a fast‑paced environment with limited information and/or time‑constraints.
• Adhere to cGMP policies and procedures, including documentation activities
• Able to work collaboratively to respond to changing priorities and challenges
• Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP, ICH, FDA , etc.).

Education Requirements:

• BA/BS degree in Microbiology, Biology, Chemistry, Engineering or related field and at least 8 years of Quality experience in a GMP‑regulated environment.

Neurona Therapeutics
490 Forbes Blvd, Suite 600
South San Francisco, CA 94080
[e-mail]