ROLE SUMMARY

Senior Quality Event Investigation Lead will be accountable for managing confirmed Significant Quality Event (SQE) case through the investigation process including root cause analysis.  The Senior Quality Event Investigation 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 Quality Event Investigation Lead will direct the SQE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required.    The Senior Quality Event Investigation Lead will be assigned to and manage T3 and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT).  Presentation to QRT requires development of a presentation which captures the salient points of the case and investigation and is at a level appropriate for senior leaders.   The presenting lead must be able to address questions from the leaders and take appropriate follow-up actions as requested.

ROLE RESPONSIBILITIES

Serious Quality Event Investigation

He or she 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 the 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.  Case summaries should require minimal edits by the approver.  Case documentation will be complete and accurate and filed as necessary to ensure inspection readiness. The Senior Quality Event Investigation Lead will perform quality review and approval of select significant quality events which have been managed by other investigation leads.

He/she will be assigned to process improvement initiatives as necessary and be expected to drive changes to the business process for case management when the need arises.  This includes reviewing and updating process documentation to reflect any changes to business process.

He/she will provide mentorship to new leads in the onboarding process and will be responsible for review, development and delivery of training material as necessary.

Support of regulatory inspections, as necessary.

BASIC QUALIFICATIONS

• BS- 15 years or equivalent
• MS/MBS – 10 years or equivalent
• PhD/MD – 5 years or equivalent

Previous Experience:

• Minimum of 10 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory.
• Regulatory inspection experience
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills
  • Written and verbal communication for a senior audience is required
• Training and proficiency in root cause analysis methodology preferred

Strong scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred

PREFERRED QUALIFICATIONS

Strong background in continuous improvement methodology (ie Lean Six Sigma) preferred.

OTHER INFORMATION

This role will interact with multiple roles within the GPD organization, as well members from Compliance, Legal, Product Supply.

This position does not have any direct/indirect reports/matrix responsibility.