Quality Director Management Systems
3 weeks ago
Role Overview
We are seeking a Quality Director to lead our Management Systems team in transforming the current state of Incoming Material testing and data management processes. This is a hands-on role requiring strategic project engagements, matrix team management, and As-Is business process and data analysis. The goal is to define the future state operating model for Incoming Material testing, rationalizing existing catalogues into clear global standards, and leveraging pharmacopeial standards to minimize custom testing requirements.
Key Responsibilities
- Lead a program team to deliver the strategy and execution plan for the transformation.
- Define and detail the GSC Incoming Material standards and strategy, leveraging best practices on harmonized data standards and common testing methods based on the Pharmacopeial standards.
- Work closely with the ERP Master data management and LES design teams to ensure clear requirements and catalogs are defined and built ready for the implementation phases.
- Translate the roll-out methodology into detailed implementation plans for the impacted sites.
- Develop the training and communication deliverables to manage the transition from the current state into the future state design.
- Define the future state Business As Usual (BaU) data and test method update processes, including change request processes and defining the appropriate governance model that will support this.
- Develop and ensure consistent and harmonized Master data structures in QC platforms are maintained across the systems and sites in alignment with Data Integrity and Regulatory requirements.
Requirements
A Degree in a Scientific, Engineering, or Chemistry discipline, with considerable demonstrated experience in Quality Control. Expert user for one or more laboratory applications, including chromatography data systems and laboratory information management systems. Significant experience in pharmaceutical laboratory testing activities, Analytical methods, and instrumentation. Experience in Data management, Data Governance, and reporting/analytics.
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