Senior Manager in Quality Management
3 weeks ago
About the Role
We are seeking a Senior Manager to lead our Quality Management team. This is a critical role that requires a strong background in pharmaceutical quality and risk management.
- Lead Root Cause Analysis for cross-functional issues and any critical risk/issue via dedicated Root Cause Investigator
- Coordinate CAPA management and advise on CAPA effectiveness checks
- Oversee CAPA closure and effectiveness implementation
- Develop training material and train business on risk management, root cause investigations and SMART CAPAs
- Contribute to the development, continuous improvement and successful implementation of a simplified and effective process, aligned with the GSK Quality Management System
- Work with relevant stakeholders to improve our understanding of the challenges and associated solutions to ensure excellence in issue management
- Act as first line of support to assist business areas navigate and discharge responsibilities relating to the process as well as address concerns or questions
- Partner with Clinical Development Quality Assurance and business partners to create and operationalise robust issue management process that support the organisation in fostering high quality culture
- Use key performance indicators to monitor performance of adoption and implementation of the process
- Facilitate the management review and oversight by proactively monitoring signals and business performance
Requirements
- Bachelors' Degree, Preferably Scientific Discipline
- Broad and robust pharmaceutical/vaccines industry background & experience in R&D, with proven record of projects successfully led in a matrix environment, including problem solving, self-discipline and operating under pressure, with changing priorities and difficult circumstances
- Proven record of robust experience (ideally in R&D) in quality- and risk management-related areas, including root cause analysis and ability to drive pragmatic, data-driven decisions, focusing on high impact areas, with attention to detail, while fully taking into account the big picture and interconnections
- Proven record (ideally in R&D) of the ability to drive performance and influence stakeholders; proven record of change management, streamlining and learning agility
- Proven record of implementing the Internal Control Framework (ICF) and, in particular, Risk Management and Management Monitoring ICF elements, in a naïve population, with successful outcome
- Expertise in essential regulatory guidelines world-wide, as well as GSK company policies and procedures, e.g. detailed knowledge of GSK SOPs, ICH and FDA regulations as they impact all aspects of drug development.
- Ability to establish and maintain good working relationships with peers, colleagues and management
- Proven ability to clearly convey information orally and in writing to audiences with varied knowledge
- Ability to work independently and make decisions with minimal supervision
About GSK
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
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