Validation Manager cross contamination (Temp position for 18 months)

Job Purpose

• The job owner has the task to support the deployment a risk-based approach for cross-contamination by providing standards and strategies to facilitate a robust and efficient validation methodology and to support as required projects linked to validation life-cycle cleaning, process and product.
• The job owner will work with the various global MSAT SMEs to deliver key GSC projects, continuous improvements and initiatives within their areas of expertise.
• The job owner will proactively support identification of high risks within area of expertise and put standards and ways of working in place to mitigate them.
• The role will work in a matrix environment and through the Community of Practices, with representation from the various Global Supply Sites, support effective implementation and maintenance of the validation standards.
• The role will support global teams and will ensure that standard strategies are deployed across sites making same products.

Key Responsibilities

• Support definition of GSC Cross-contamination/Validation / PLM QMS Standards, and creation of tools/templates/guidance ensuring these are up to date with current and emerging regulatory requirements and reflect industry best practices.
• Work in partnership with the various global MSAT Validation Leads to deliver key GSC projects, continuous improvements and initiatives within areas of expertise (cross-contamination focus)
• Support local experts and global teams as required (e.g.  inspections preparation, response writing, risks, observations, deviations, improvement initiatives, remediation, CAPA).
• Through the Global Validation Community of Practices identify areas for standardization and implement those agreed standards across GSC. Use the Global Validation Community of Practices to support the sites with specific issues and opportunities for improvement,
• Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/ new technologies, industry standards and registered risks pertaining to area of expertise.
• Development / application of a consistent training approach/packages for cross-contamination/ Validation / PLM across GSC.
• Identify opportunities for implementing Digital, Data and Analytics improvements.
• Building partnership with relevant functions to drive E2E standardization of processes across R&D and Commercial.
• KPIs in place driving continuous improvement of the standard and its implementation across GSC.

Why You

Basic Qualifications

• University Degree in scientific discipline
• Knowledge on cross-contamination and risk assessments
• Previous experience of working with multidisciplinary teams
• Risk Management/ Project Management
• Regulatory knowledge related to the specific expertise
• Strong technical writing skills

Leadership Behaviours

• Strong influencing skills across all the divisions/sites, MSAT, Quality and R&D.
• Key influencing and support within GSC as high level of matrix working with sites and CoP’s across all of GSC.
• Multicultural mindset

Preferred Qualifications

• University Degree in scientific discipline
• Ability to work in a matrix organization on a global basis, able to build and sustain personnel relationships with peers and subordinates.
• Think strategically and act with a high level of integrity to establish effective plans of action.
• Autonomous, proactive, with a positive and constructive attitude

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.

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