https://bayt.page.link/PBMY52VRgPBoDWcs8
Create a job alert for similar positions

Job Description


Years of Experience: 10 to 15 Years
Key Responsibilities


  • Lead Root Cause Analysis for cross-functional issues and any major 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



  • 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.


Important notice to Employment businesses/ Agencies


GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.


GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.


If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.         


You have reached your limit of 15 Job Alerts. To create a new Job Alert, delete one of your existing Job Alerts first.
Similar jobs alert created successfully. You can manage alerts in settings.
Similar jobs alert disabled successfully. You can manage alerts in settings.