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About the Role

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.

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 escalate 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.

Requirements

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.
Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines.
In-depth 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.).

Skills

Project Management
Quality Assurance
Quality Systems
Harmonization of quality systems
Upgrade of quality systems
BLA readiness
MS Office
Digital tools
Data interpretation
Problem-solving
Technical presentation
Negotiation
Strategic thinking
Decision-making
Analytical thinking
Creative thinking
Innovative solutions
Change management
GMP
ISO
EU GMP
ICH
FDA

Location

South San Francisco, CA

Work Type

On-site

Experience Level

Senior
8 years of Quality experience in a GMP-regulated environment

Education Level

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

About the Company

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.