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.
- BS- 15 years or equivalent
- MS/MBS - 10 years or equivalent
- PhD/MD - 5 years or equivalent
- 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
Strong background in continuous improvement methodology (ie Lean Six Sigma) preferred.
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.