Quality Lead for GH Medicines R&D Clinical Development London, England
Job description
Posted Date: Aug 18 2023
Quality Lead for GH Medicines R&D Clinical Development
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:
Work with clinical and clinical operations teams to ensure that emerging HSR, Patient Safety and other clinical issues are appropriately documented, escalated, and addressed.
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.
Assure the Global Health tracker for any external engagement is updated for Clinical activities.
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.
Experience in CAPA management and ability to lead small projects of a strategic nature and coordinate teams to successful and effective delivery.
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 and 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 and 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.
Valuable skills and Knowledge
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.
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 leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
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 status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
