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Incoming materials quality les business change director

London
GSK
Director
€80,000 a year
Posted: 13 April
Offer description

You will be responsible for leading a program team to transform the current state Incoming material testing and data management processes from multiple ways of working into a new standardized approach across the GSC supply chains. This is a hands‑on role and responsibilities will include both matrix team management as well as strategic project engagements. The role will require As‑Is business process and data analysis which will then be used to define the future state operating model for Incoming Material testing. Goals include rationalizing existing catalogues into clear global standards, leveraging pharmacopeial standards to minimize custom testing requirements and defining the operating model around ongoing business as usual updates to Incoming materials used through the company. You will work closely with the Incoming Materials Quality Operational teams, Quality, Strategic Product Quality and Quality Systems and Data teams to ensure the Incoming material requirements are clearly designed ready for the Laboratory Execution teams to then implement and deploy across GSC.


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.


Qualifications

* Minimum 2 days per week onsite.
* 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, addressing 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 resolution skills.
* Technical breadth in order to build integrated program plans.
* Strong knowledge of GPS desirable.
* 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.


Equal Opportunity Employment

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.

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