Business Lead Investigator

1 week ago

Stevenage, Hertfordshire, United Kingdom GSK Full time

Site Name:
UK - Hertfordshire - Ware RD, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, Upper Merion, USA - Pennsylvania - Upper Providence

Posted Date:
Jan

We are looking for a Business Lead Investigator to join our team.


As the Business Lead Investigator, you will ensure that Medicine Development and Supply is in a compliant state with respect to regulations and GSK policies/procedures.

You will participate in the robust and timely investigation and recording of deviations across MDS, leading the root cause analysis process.

In addition, you will assist with the identification of trends and deliver inspection-ready investigation reports.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.


We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

In this role you will

  • Lead complex or Critical deviations with the potential for direct impact on regulated systems or clinical supplies.
  • Provide support to the MDS lines by leading or facilitating the root cause analysis process associated with deviations and Independent Business Monitoring (IBM).
  • Support Customer Complaints and Vendor Complaints as required by the business.
  • Ensure the correct identification of root causes during investigations, document the outcome in a clear and accurate manner, while effectively communicating and collaborating with lines in the management and delivery of investigations.
  • Lead matrix teams/subteams and supports significant investigations, activities, or risk mitigation actions in areas of expertise.
  • Contribute as Subject Matter Expert to the development of core business practices for the management of deviations, customer and vendor complaints, as well as contributing to the building of a compliance culture through the design and delivery of engagement communications, training, and activities.
  • Perform trend analysis and provide metrics on quality events to support recommendations for proactive interventions and continuous improvements.
  • Leads or supports training in quality processes and provides support to team members with less experience of root cause analysis

_ Why you?_

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's degree or equivalent in a scientific or related discipline.
  • Experience working in the pharmaceutical industry with a sound scientific understanding and background.
  • Experience in leading and resolving complex deviations.
  • Knowledge of the relevant pharmaceutical industry regulations.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

  • Proven ability to effectively assimilate and communicate compliance data to management for the purpose of driving corrective actions and mitigating risks.
  • Able to negotiate and influence during investigations.
  • Able to communicate and report clearly in an engaging and memorable way, tailored for targeted audiences.
  • Demonstrated ability to work in a matrix in order to deliver robust investigations.
  • Ability to collaborate both within department and beyond department as needed during investigations.
  • Proven ability to drive for results within agreed timeframes.
  • Actively seeks to design and deliver improvements to quality processes, driving towards efficiencies.

Closing Date for Applications - 16th February 2024 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.

CMCDevelopmentGSK

Why Us?


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 organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadershi

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