The Senior Issue Lead will be accountable for:

• Quality Events: managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis. 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.
• Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation.
• 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

Quality Event Investigation:

The Senior Issue Lead will ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable a meaningful investigation with appropriate quality outcomes which includes a case summary which meets defined quality standards and can be used for a regulatory inspection. The Senior Issue Lead will perform quality review and approval of select quality events which have been managed by other investigation leads. He/she will be assigned to process improvement initiatives and special projects as necessary and be expected to drive changes to the business process for case management when the need arises.

Training and Technology:

This individual will also be required to mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted 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 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.

Education:

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

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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