Hybrid Incoming Materials Quality Business Change Director

Posted 4 hours ago

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About the role

  • 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

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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