QA Investigations Associate Manager

Legend Biotech is seeking QA Investigation Associate Manager as part of the Quality team based in Raritan, NJ. 

Role Overview

The QA Investigation Associate Manager will be a part of the Raritan Investigation Excellence Team. This individual will be responsible for the supervision of a team of QA Investigation Leads, NC/CAPA Investigation Support, Investigation Metrics ownership, Internal/external audit readiness/support, as well as supporting continuous improvement projects within the Raritan Investigations organization. The QA Investigation Associate Manager is an exceptionally organized, logical professional who has the experience necessary to enhance the quality of our investigations, ensure compliance with applicable procedures, drive efficiency of our execution, and robustness of our Corrective and Preventative Action (CAPA) plans to the next level of accuracy, effectiveness, and compliance.

Key Responsibilities  

•  Supervise QA Investigation Leads:
  • Lead daily touch point meetings with the QL Supervisor Team and monitor QA Investigation Lead workload.
  • Provide guidance to quality leaders in investigation performance, process knowledge of cell and gene therapy manufacturing, and compliance to ensure that investigations reviewed by the team adhere to a high standard of excellence
• Investigation Support:
  • Ensuring the manufacturing and investigation processes are compliant with all applicable regulatory requirements.
  • Approve the change in scope or level of an investigation.
  • Lead the daily triage meeting for nonconformance initiation.
  • Escalation of events that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release to management.
    
  • Ownership or supporting the creation of investigation execution related documents (SOP’s, Work Instructions, Job Aides)
  • As a member of the CAPA review Board, ensure that CAPA and EC plans are robust enough to drive the residual risk for an event to the lowest extent possible after implementation and that an acceptable recurrence level is justified when recurrence cannot be fully eliminated.
• Investigation Metrics Ownership:
  • Ensure the health of the investigation process by owning and monitoring investigation metrics and implementing actions when metrics indicate a negative trend or failure to meet accepted criteria.
• Internal/External Audit Readiness/Support:
  • Serve as Subject Matter Expert in preparation for and during both internal and external audits, including FDA, EMEA, etc.
  • Ensuring a high level of competency and audit/inspection readiness of the overall Raritan investigation team. Coaching quality leads to audit readiness and preparing them and quality records for audits/inspections.
• Continuous Improvement Project Support:
  • Representing quality on the project improvement team, ensure process improvements are implemented incorporating quality risk management principles and that current effective reference documents supporting investigations are updated appropriately.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, and Quality Assurance.

Requirements

• A minimum of a bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 5 years of operations or Quality Assurance experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• A minimum of 2 years of experience managing a team.
• Significant experience utilizing LIMS, SAP, MES, EMS/BMS, training, and quality tracking systems.
• Demonstrated experience in handling/leading complex multi-disciplinary investigations in a cGMP environment.
• Experience partnering with various levels of leadership across complex organizations
• Experience utilizing risk assessment tools and a working knowledge of ICH Q9 guidance on risk assessment.
• Ability to build strong partnerships and effectively integrate with Internal and external partners to drive projects/programs forward in a matrixed environment.
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