Job description
Site Name:USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK – London – New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham
Posted Date:Nov 22 2024
R&D Quality & Risk Management will enableGSKR&D to accelerate and innovate to create greater efficiency and faster product development through proactively partnering, being prevention focused by driving Quality by Design in the Product Life Cycle and be a game changing force within the organization.
As a member of the R&D Risk Management (RM) Team, theDirector, Risk Management AIML/ HEOR /EPIwill support the Artificial Intelligence and Machine Learning (AI/ML) Team to ensure they identify and manage risks relevant to their objectives across R&D, more broadly, act as the functional backbone of the Internal Control Framework (ICF), while ensuring close connection with GSK Enterprise Risks and cross-functional synergies. The position holder is a deep subject matter expert and responsible in driving continuous improvement and supporting the embedding of a risk-based responsible and ethical use of AI/ML approach across R&D that will further drive understanding, predicting and improving health outcomes at both the individual and population levels.
The position holder is a risk management professional and responsible for identifying, assessing and mitigating risks across the organisation. This includes financial, operational and strategic risks as well as other potential threats. The risk manager will actively promote a culture of proactive risk management across the organization.
Key Responsibilities:
In this role you will:
Partner with the Senior Leaders in the assigned business lines to create a culture of openness and transparency where staff speak up and leaders take action
Partner with the R&D senior leaders to integrate risk management into their business performance and planning
Facilitate the management review and reporting for the aligned R&D senior leaders and their leadership team by proactively monitoring signals and business performance to drive continuous improvement and further enhance the quality of data-driven decision-making
Partner with the assigned business lines to identify and manage inherent and emerging business risks which individually, or collectively, influence the achievement of the business objectives, protect the license to operate and allow the business to understand the current level of control within their business activities
Contribute to the development, continuous improvement and successful implementation of a simplified and effective RM process, aligned with the GSK Quality Management System (QMS), including effective deployment of quality and risk management councils for the assigned business lines
Support the business lines on how to implement effective RM approaches, with continued focus on high impact risks, including strong connection with Enterprise Risk management and cross-functional synergies
Act as RM Process Owner for the assigned business lines
Collaborate with the Quality and Compliance organizations, to build an integrated model that links risk, issues and Corrective Actions and Preventative Actions (CAPAs) and support the business in the conduct of root cause analysis, development and implementation of CAPAs and associated effectiveness checks
Contribute to the development of training material and train the assigned business lines on risk management (process, methodology, tools); act as point of connection for training on root cause investigations and SMART CAPAs
Support the assigned business line in implementing an effective Internal Control Framework (ICF), including fit-for-purpose Management Monitoring, informing both risk and audit universe
Act as first line of support to assist business areas navigate and discharge responsibilities relating to policies, Standard Operating Procedures (SOPs) and guidance related to their specific business area as well as address concerns, questions, or issues relating to business unit policies, procedures and processes
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Risk management experience in the pharmaceutical/vaccines industry, finance or business, working with multiple complex projects in a matrix environment
Experience in R&D in quality- and risk management-related areas, including root cause analysis and
Experience using risk management tools and methodology
Experience (ideally in R&D) in Quality/audit/CAPAs, executed with multiple stakeholders and conflicting interests
Experience implementing the Internal Control Framework (ICF) and, in particular, Risk Management and Management Monitoring ICF elements
Experience with regulatory guidelines worldwide, ICH and FDA regulations as they impact all aspects of drug development.
Experience understanding financial markets or business operation
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Background in Problem solving, self-discipline and operating under pressure, with changing priorities and difficult circumstances
Proven record (ideally in R&D) of the ability to drive performance and influence stakeholders, including Sr Leaders; proven record of change management, streamlining and learning agility
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
Experience with GSK company policies and procedures, e.g. detailed knowledge of GSK SOPs
#LI-GSK
Please visit GSK US Benefits Summaryto learn more about the comprehensive benefits program GSK offers US employees.
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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