Director, Risk Management (Biostats)

The Director, Risk Management (Biostats) will enable R&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, the RM Director will support seamless execution of RM within the assigned business lines and, 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 risk management professional and responsible for identifying, assessing and mitigating risks across the organization. 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:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• 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:

• A degree in a Scientific, Finance, Business or Economics Discipline

• 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

• Experience using risk management tools and methodology

• Experience to drive performance and influence stakeholders, including Sr Leaders; including change management

• 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