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Job Description
- Ensure implementation of GSK CH Quality Management System and GMP requirements at country level
- To monitor and review performance of metrics against the targets and liaise periodically with General Managers and Regional Commercial heads to agree improvement areas
- Determine the responsibilities of LOC Quality Staff to ensure effective, overall quality management and continuous improvement of supply chain activities in LOCs
- Create and identify opportunities to share information, documentation and knowledge between LOCs and driving simplification and improvements.
- Ensure timely and effective escalation of quality incidents and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation as a manufacturer of quality products and when necessary direct LOC’s to manage incidents via the PIRC process and take on the role of PIRC Chair for incidents relating to LOC Quality in Area. Act as a coach/provide advice to the PIRC secretary and other PIRC chairs.
- Actively manage the country quality teams and set up their development and objective targets and develop a plan of support visits to LOCs based on people management needs and risk.
- Act as a quality contact for Supply chain and commercial teams as relevant in relation to quality and compliance issues
- Coordinate LOC and Distribution Center site readiness for Health Authority inspections and proactively manage interactions and commitments to HA.
- Ensure effective Quality Management of New Product Introduction, the distribution network in Area , complaint management, artwork management and ensure Duty of Care and Product release is conducted in line with local regulatory requirements
- Work in a matrix organization with the global documentation and systems group to ensure appropriate LOC Quality Global SOPs and processes are developed and then lead the implementation of the SOPs or process across the Area LOC.
- Ensure that CMO facilities and systems meet and maintain current regulatory requirements & expectations and report all potential and actual cGMP/Regulatory compliance issues. Ensure approved Quality Agreements are in place for assigned CMOs.
- Ensure there is appropriate communication, cascading of information, prompt escalation of significant issues or risks across the organization, driving prompt resolution of issues. Actively participate in GSK management review forums. Drive periodic review of quality systems at CMOs and lead Quality agenda in relevant Business Review meetings.
Job Requirements
- First Degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge
- Quality experience within the industry, and application of Quality Systems
- LOC Quality Manager is a senior manager position with decision making responsibilities that could impact the
- This role requires a deep level of GMP/GDP knowledge and problem solving skills due to the often complex and technical origin of product quality issues and events.
- Exceptional leadership skills
- Excellent oral and written communication skills
- Proven influence and impact skills across business levels and functions
- Strong interpersonal and negotiation skills
- Problem identification and solving skills
- Competent people manager and able to identify and promote talent
- Ability to enable and drive change
- Able to work effectively in English
- Self-starter, able to schedule and progress workload on own
- Experience of working with and leading cross-site and multi-functional teams
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