· Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.
· 4+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
· Minimum of 2 years working within quality systems managing deviation and CAPA records.
· Experience authoring deviation and CAPA records
Skills:
· Expertise in GMP compliance and FDA/EMA regulations.
· Demonstrate excellence in written and verbal communication.
· Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
· Innovative, proactive, and resourceful; committed to quality and continuous improvement.
· Ability to anticipate and mitigate challenges.
Key Responsibilities:
· Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date.
· When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
· Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure.
· Owns and investigates department-specific trend deviations.
· Assess trend details to ensure accuracy and alignment across the team.
· Facilitate in-depth root cause analysis to determine additional process and system failure modes.
· Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend.
· Determine if previous identified CAPA are sufficient to reduce the trend by defined targets.
· Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations,
· Applies HOP (Human and Organizational Performance) principles to investigations.
· Uses both soft-skills and technical skills to drive the deviation and CAPA processes.
· Completes deviations that are thorough, accurate, and complete.
· Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase.
· Performs investigations and root cause analyses that are commensurate to the event being investigated.
· Understands multiple RCA tools and when, where, and how to apply them.