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.
The QA Manager will oversee and partner with operational teams to ensure compliance for Neurona. This role is responsible for ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The QA Manager is responsible for quality activities in accordance with Neurona policies, standards, procedures, and regulatory requirements.
Specific areas of responsibility include, but are not limited to, performing Acceptable Quality Level (AQL) inspection, printing batch records for use, overseeing product pulls, and reviewing deviations, change controls, and other event records. This position interacts cross-functionally with the Manufacturing, Operations, Regulatory, and Quality Assurance groups to ensure that all manufacturing areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.
Responsibilities:
• Track, analyze, and report QA metrics
• Review and approval of facility validation protocols, data, and reports
• Review and approval of controlled documents such as protocols, master batch records, specifications, and standard operation procedures
• Review and approval of product and raw material specifications
• Independent review of executed batch records
• Perform raw material release
• Review and approval of GMP shipments
• Management of temperature excursions
• Provide routine on-the-floor Quality oversight to ensure collaborative triage of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems.
• Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.
• Advanced ability to synthesize information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.
• Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing.
• Serve as a subject matter expert supporting others to navigate the Neurona quality management system including but not limited to deviation and CAPA action management, disposition decisions, and batch record management.
• Implement “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
• Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.
• Proactively identify and address quality risks and critical issues, drive mitigations with the aid of cross-functional partners and escalate to senior management as needed.
• Lead walkthroughs with peers to identify and remediate operational or quality issues.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
• Regularly spend time coaching and mentoring operators while on the manufacturing floor.
• Work with Regulatory and Clinical Operations supporting Neurona’s clinical trials
• Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations.
• Provide and deliver ongoing training for GMP, GDDP, and Data Integrity.
• Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures.
• Other additional QA tasks as directed by QA Management
Required Qualifications:
• Minimum of 5 years of Quality experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred).
• Strong foundation in the Clinical Supply Process or equivalent pharma/healthcare supply chain process
• Must be able to gown for Grade B (ISO 7) manufacturing space
• Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines.
• Strong experience with managing quality systems records, conducting investigations/deviations
• In-dept knowledge of cGMP
• Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred.
• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
• 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
• Ability to think strategically, meet deadlines, and support work prioritization
• Ability to negotiate and influence to craft mutually beneficial solutions
• Ability to motivate and foster a positive team environment
• Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality
• Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within 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 understand complex problems with multiple datum/variables and articulate practical solutions.
• Demonstrated experience working with GxP electronic systems such as laboratory information management systems or Quality Management Systems such as TrackWise or Veeva.
• 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 wear appropriate personal protective equipment
• Able to work collaboratively to respond to changing priorities and challenges
• Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP, ICH, FDA , etc.).
• Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred.
• Actively participate in group and project teamwork, project and process improvements
• Ability to support manufacturing processing that occurs during the weekend or at late night/early morning hours
Education Requirements:
• BA/BS degree in Microbiology, Biology, Chemistry, Biochemistry, or related field and at least 5 years of Quality experience in a GMP-regulated environment.
Interested in learning more about our science and our team? Please visit our website at www.neuronatherapeutics.com
This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
Interested in joining a cutting-edge team dedicated to advancing cell-based therapies for neurological diseases? Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
Recruitment Fraud Notice
We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.
