RCI & CAPA Senior Manager

4 weeks ago

Stevenage, United Kingdom GSK Full time
Job description
Site Name: Bengaluru Luxor North Tower, GSK HQ, Poznan Pastelowa, UK - Hertfordshire - Stevenage, Warsaw
Posted Date: Nov 5 2024

Years of Experience:16 to 20 years

Key Responsibilities

  • Lead Root Cause Analysis for cross-functional issues and any critical risk/issue via dedicated Root Cause Investigator 

  • Coordinates cross-functional CAPA management and advise on CAPA effectiveness checks 

  • Oversee the CAPA closure and effectiveness implementation 

  • Develop training material and train business on risk management (process, methodology, tool), 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 the 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 hight 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

Education Requirements

Bachelors’ Degree, Preferably Scientific Discipline

Job Related Experience

  • 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. 

  • Six Sigma Black Belt certification

Other Job-Related Skills 

  • Advanced ability to problem solves, using critical thinking capabilities 

  • Ability to establish and maintain good working relationships with peers, colleagues and management 

  • Demonstrated track record in leading and effecting significant change, innovation and results  

  • Ability to influence, to anticipate and analyse complex and business problems/opportunities 

  • Proven ability to clearly convey information orally and in writing to audiences with varied knowledge 

  • Ability to achieve work through others who do not report directly to them with guidance 

  • Ability to work independently and make decisions with minimal supervision

Why 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 prevent and treat disease with vaccines, specialty and general medicines. 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).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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