Senior Issue Lead- FSP

PXL has an exciting FSP opportunity for a Senior Issue Lead. The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. The Senior Issue Management Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required. The Senior Issue Lead will be assigned to and manage critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team.

Responsibilities

• Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation.
• Quality Event Investigation- ensure that the confirmed case is investigated appropriately and ensuring the investigation timelines are met
• Training and Technology- mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted Quality Event
• Audit and Inspection Coordination- This individual may be assigned additional focus areas in audit coordination or inspection coordination
• Quality Compliance Assessment- Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes
• Root Cause Analysis- This individual will also be required to apply a root cause methodology and/or due diligence approach to assigned QEs. This
  individual may either lead QE cases from start to finish

Major areas of focus will include:

• Audit coordination for GCP related process and preferred CRO vendor audits
• CAPA management
• Directing Inspection readiness and providing inspection support for GCP sponsor inspection activities

Qualifications

• BS – 10+ years or equivalent
• MS/MBA – 9+ years or equivalent
• 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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