Senior Quality Issue Lead - FSP

Overview

The Senior Issue Lead will be accountable for leading quality event investigations and coordinating related activities to ensure timely, compliant outcomes.

Responsibilities

Quality Events : managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis. Ensure investigations are conducted thoroughly, within required timelines and to compliance requirements, including adequacy of root cause analysis and the appropriateness of communication regarding the case. Direct the QE team in proposing appropriate Corrective and Preventive Actions and ensure completion is evidenced in documentation as required. Manage Critical and other complex cases, especially those that require presentation to senior leaders as part of the Quality Review Team.

Audits and Inspection Coordination : Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation.

Quality Event Investigation : Ensure that each confirmed case is investigated appropriately, including meeting investigation timelines and performing pre-work to enable meaningful investigations with quality outcomes. Produce case summaries that meet defined quality standards and can be used for regulatory inspection. Perform quality review and approval of select quality events managed by other investigation leads. Be assigned to process improvement initiatives and special projects as necessary and drive changes to the business process for case management when needed.

Training and Technology : Mentor and train Issue Leads to ensure those reviewing submitted issues are qualified to assess and categorize Quality Events.

Audit and Inspection Coordination

This individual may be assigned additional focus areas in audit coordination or inspection coordination, including inspection responsibilities around :

Directing asset / study team colleagues to ensure successful inspection and audit outcomes

Communicating audit and inspection progress and needs to internal stakeholders

Serving as the point of contact for Regulatory Quality Assurance related to audit and inspection CAPA management

Quality Compliance and Root Cause

Quality Compliance Assessment : Plan, lead and report on Quality and Compliance Assessments related to CD&O processes.

Root Cause Analysis : Apply root cause methodology and due diligence to assigned QEs. May lead QE cases from start to finish.

Education

BS – 10+ years or equivalent

MS / MBA – 9+ years or equivalent

Previous Experience

Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and / or regulatory

Regulatory inspection experience

Process and system management experience

Detailed knowledge of clinical trial processes and relationships required

Knowledge of GCP requirements and applicable SOPs and regulations

Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills

Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred

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