Director responsible for leading the Incoming Materials program transformation at GSK. Harnessing technology and data within pharmaceutical manufacturing to improve processes.
Responsibilities
Lead the Incoming Materials program team which is a matrix team to deliver the strategy and execution plan for the transformation
Define and detail the GSC Incoming Material standards and strategy leveraging the 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.
Define a roll-out methodology for the new processes and standards that can accelerate the delivery across the GSC sites.
Working with the LES program teams 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
Degree in a Science, Computer Science, Chemistry or other related discipline
Expert user for one or more laboratory applications including chromatography data systems (such as Empower) and laboratory information management systems (such as Labware or LabVantage)
Significant experience in pharmaceutical laboratory testing activities, Analytical methods and instrumentation.
Experience working with the Pharmacopeial standards
Experience in Data management, Data Governance and reporting/ analytics.
Ability to create a healthy, engaged and inclusive working environment that is sustainable over time.
Organize, manage, and direct a complex variety of activities, people and tasks based at multiple locations globally, prioritizing conflicting demands in a measured, business focused way.
Ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers to achieve business goals and objectives
Ability to analyze complex data/information/scenarios and make rational, risk based decisions which are communicated and/or escalated clearly and confidently.
Addresses challenges to Quality and compliance decisions/positions in a knowledgeable and assertive manner.
Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers.
Excellent consultative, listening, communications and analytical skills
Must be flexible, adaptable and a strong team player
Negotiation and conflict resolutions skills
Technical breadth in order to build integrated program plans.
Strong knowledge of GPS desirable
Technical Business and Technical expertise in pharmaceutical computer systems delivery.
Broad Knowledge and experience to understand the links and identification / management of Risks between the Business, Technical, Operational and Support aspects of project delivery.
Experience with Data management, standards and governance
Experience and knowledge of program and system life cycles.
The ability to plan effectively in order to deliver sustainable business change programs
Breadth in quality systems principles and practical application of QMS and Regulatory submission filings in multiple complex markets.
Ability to motivate highly skilled and trained individuals.
Benefits
Health insurance
Flexible working hours
Professional development opportunities
Job title
Incoming Materials Quality Business Change Director
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