Senior Manager, Quality Program Management
- Compensation
- Not disclosed
- Location
- South San Francisco, CA
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 8+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.).
Full description
Senior Manager, Quality Program Management
Reports to: VP, Quality
Location: South San Francisco, CA
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.