Incoming Materials Quality Business Change Director

Role Overview

• 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.

Tech Stack

• ERP

Benefits

• Health insurance
• Flexible working hours
• Professional development opportunities