Quality & Compliance Lead for Gh Medicines R&d

hace 2 semanas

Tratamiento De Aguas Goloso El, España GSK A tiempo completo

Site Name:
GSK Tres Cantos, Madrid

Posted Date:
Jul

GHM
R&D Business Operations Clinical Lead**
Job Purpose
The GSK Global Health Medicines R&D unit researches and develops transformative products and technology to prevent and treat infectious diseases which disproportionately impact people in low and lower middle
- income countries. We achieve this by using our science, our partnerships, and the knowledge we ́ve gained from addressing the world ́s biggest health challenges. These partnerships usually comprise research partners like institutes or academics as well as funding agencies or organizations, making the Global Health model unique within GSK. We are looking for a Quality & Compliance expert for the Global Health Medicines R&D unit, to support Clinical Development activities.

Key responsibilities


This role will work in conjunction with the GH Medicines R&D Clinical Development Team, the GHMR&D Business Operations Team and the Clinical Operations Team to provide Business operations support focused on Quality and Compliance activities.


Individuals will be expected to:

  • Lead Risk Management for the Clinical activities.
  • Be a member of the Tres Cantos R&D Quality Team, including the GH Medicines R&D Risk Management & Compliance Board and the GHMR&D Clinical LT
  • Contribute to GH Medicines R&D Management Monitoring universe and plan definition
  • Coordinate and perform Management Monitoring of key business activities
  • Oversee or undertake analyses of MM trends required to better understand a potential business issues and emerging risks and inform continuous improvement activities.
  • Support the Enterprise Risk Subject Matter experts
  • Work with all relevant stakeholders to ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives and ALCOA+ principles
  • Work with relevant stakeholder across GH and R&D to ensure that the activities conducted in R&D environment are performed in accordance with GLP, GCP, local, corporate, and relevant international regulations (as appropriate)
- "Process improvement projects, including GSK processes implementation in GHMRD, with clear expected outcomes

  • Work with clinical and clinical operations teams to ensure that emerging HSR, Patient Safety and other clinical issues are appropriately documented, escalated, and addressed
  • Experience in CAPA management
  • Ability to lead small projects of a strategic nature and coordinate teams to successful and effective delivery
  • Assure the Global Health tracker for any external engagement is updated for Clinical activities

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

  • University Degree in Science
  • Understanding of drug development and clinical trial conduct
  • Previous experience in Clinical Operations will be considered
  • Provide knowledge of the ALCOA CCEA principles
  • Understanding of ABAC / Due Diligence requirements for clinical trials
  • A disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence.
  • Ability to think in terms of the big picture while also maintaining an appropriate attention to detail. Uses excellent analytical skills and makes decisions with sound judgment
  • Ability to work in a matrix environment (across the GH organisation and across GSK BUs when required).
  • Ability to step into areas without prior business Line experience and come up to speed quickly with overall context and high level of understanding.
  • Skilled communicator: demonstrates skills in networking, collaborating and engaging people internally and externally and can communicate effectively to achieve project goals
  • Job Posting end date: 09/08/2023_


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.

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 leadership reflects our GSK workforce.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital sta

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