Senior Quality Lead

Description:

This role sits within the GMP Quality function but is aligned and foccused to support GSK's wider business activities relating to acquisitions and divestments.

The Senior Quality Lead - Business Development reports to the Senior Director for External Quality Business Development. The role supports the assessment of potential Business Development opportunities and External Suppliers by conducting Due Diligence (including scoping visits and impact assessments). Depending on project scope, the role provides oversight and management of Quality implementation plans relating to the divestment or integration of assets.

This role works very closely to establish effective working relationship with assigned project team members to ensure GSK's product quality and reputation is protected during engagement of external teams (supporting implementation of new External Suppliers or for significant changes to the existing GSK network). These include working closely with key contacts in Quality, Regulatory, Business Development and CMC (and others).

This Quality team are routinely involved with projects / assets with significant business value.

Key Responsibilities (include)
 

• Assess potential External Partners by Due Diligence activities to identify risks or required Quality Improvement activities.
• Manage current and future state analysis for Quality functional deliverables for different Business Development or Network Strategy projects.
• Manage audit readiness activities for new External Supply sites or for changes in the GSK Network.
• Manage Quality Agreement negotiations between appropriate internal and external stakeholders.
• Ensure effective and timely management of information from sites and between project functions, including performance management of project workstream activities.
• Identify and manage Quality and Compliance risks that arise from projects, including escalation of serious cGMP/Regulatory compliance issues following internal procedures.
• Drive robust RCA and problem-solving mindset to ensure actions are delivered to effectively manage risks.