Incoming Materials Quality LES Business Change Director

GSK
Stevenage, United Kingdom
5 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English

Job location

Stevenage, United Kingdom

Tech stack

Data analysis
Data Governance
Data Integrity
Data Systems
Global Positioning Systems (GPS)
Laboratory Information Management Systems
Information Technology
Data Management

Job 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 This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • 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 defininng 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., This role is hybrid with an expectation to be on-site for key meetings and activities. Min 2 days per week onsite.

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

About the company

At GSK we manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply., Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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 (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Apply for this position