JOB RESPONSIBILITIES:

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 within CD&O/Clinical to ensure successful inspection and audit outcomes

• Communicating audit and inspection progress and needs to CS&O/Clinical 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

QUALIFICATIONS:

•            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.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Issue Mgmt Group Lead, or Head of Issue & CAPA Mgmt

• Interacts with cross-functional study teams in the conduct of investigations of confirmed QEs