Senior Specialist, Quality Systems, LPO

Role Summary

The Senior Specialist for Quality Systems at the S-12 Cell Therapy Manufacturing is responsible for the oversight and management of the Corrective and Preventive Action (CAPA), Supplier Corrective Action Request (SCAR), Change Control, Deviation and complaints processes. The role serves as local process owner (LPO) for the CAPA, SCAR, Change Control, Deviation, and Complaint modules and associated local procedures and supporting processes. This position requires cross-functional collaboration and directly impacts site quality performance and continuous improvement initiatives.

Responsibilities

• Manages Change Control, CAPA, Deviation, SCAR, and Complaint Quality Systems for all GMP activities and collaborates with responsible cross-functional areas to ensure timely completion.
• Run the Change Control Process, CAPA, Deviation Review Board, generate meeting minutes, follow up on action items, and facilitate resolution when required.
• Compile applicable process metrics, identify trends, and escalate accordingly.
• Provide SME support during internal and health authority inspections of the facility.
• Communicate effectively with cross-functional stakeholders on matters related to the change control process.
• Review and approve CAPA and Change Controls.
• Support Quality Systems harmonization efforts.
• Perform other tasks as assigned by manager.

Qualifications

• College or university degree required.
• 4-7 years of experience in cell therapy, pharmaceutical or related industry.
• An equivalent combination of education and experience may substitute.
• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Strong authorship and ability to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles.
• Ability to recognize quality issues, interpret problems, and propose solutions for complex issues.
• Understanding of continuous improvement and the ability to improve compliance and efficiency of the quality system.
• Ability to prepare and convey data analysis to management and others with clarity and accuracy.
• Self-directed, able to complete routine tasks independently and make decisions within the subject matter area; escalate outside established processes.
• Moderate direction required for more complex tasks.
• Comfortable providing input/guidance in change control technical writing and training/guidance to system users as needed.
• Ability to recognize conflict and notify management with proposed resolution.
• Ability to prepare written communications and clearly convey problems to management.
• Able to support internal and health authority inspections of the facility.

Skills

• Quality systems management
• Change control process
• CAPA/Deviations/SCAR/Complaint handling
• Data analysis and metric reporting
• Cross-functional collaboration
• Technical writing and communication
• Regulatory inspection readiness

Education

• College or university degree required.

Additional Requirements

• On-site role (LI-Onsite).