About the role

As a Associate Director, Third-Party Programme Management, CQA, you will be expected to deliver independent quality oversight and management to GSK R&D as a valued partner acting as the single point of accountability for one or more clinical development Third-Party Providers; and ensure delivery of an effective independent audit programme that provides assurance that clinical trial activities governed by GCP and related regulations undertaken by and/or on behalf of GSK are compliant with relevant international regulatory agency regulations / guidelines, GSK policies / procedures, and are conducted in accordance with accepted principles for clinical trial research.

What will be some of your responsibilities?

• Implement and manage the QA audit programme for one or more Third-Party Providers: develop and maintain the in-scope audit universe and propose a fit-for-purpose and risk-based strategy for the yearly audit planning, in accordance with needs and requirements of clinical teams, partner with clinical teams and/or relevant stakeholders to ensure appropriate risk prioritisation, scheduling, and tracking of QA audits. Provide active support during root cause analysis and support CAPA development

• Lead the negotiation, review and implementation of Quality Clauses/Agreements in partnership with clinical teams and Third-Party Provider stakeholders

• Act as GCP SME for Risk Due Diligence and Technical Qualification of Third-Party Providers.

• Generate compliance statements for the Clinical study report where audit activities have been performed as requested by the clinical teams

• Provide support to CQA RII in the co-ordination and management of Regulatory Inspection activities related to Third-Party Providers. Serve as the main point of contact for inspection preparation partnering with risk managers to ensure business function is prepared for both national and local inspections (FDA, EMA, MHRA, etc.). Ensure identification and mitigation of known quality issues and potential GCP compliance risks impacting Third-Party Providers. Provide support in the root cause analysis activities for inspection findings identified impacting Third-Party Providers and support the business in development of responses

• Coordinate, manage and/or lead investigations of significant quality issues impacting Third-Party Providers, support root cause analysis activities and ensure subsequent corrective and preventative actions provide necessary remediation. Ensure appropriate escalation as per GSK global policies and processes.

• Provide proactive and regular oversight and communication of trends, risk identification, analysis and performance metrics from QA audit and all investigation and inspection activities within the business function, across R&D and with the Third-party Provider to ensure effective implementation of controls, management monitoring and independent business monitoring

• Establish strong working relationships with a network of contacts including clinical project team members, business function leaders, Risk Managers and Ethics & Compliance Officers

• Maintain an up to date and in-depth knowledge of appropriate national and international GCP legislation, regulation and guidelines; and the impact to assigned business area processes and procedures

• Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility.

• Support local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility and/or expertise. Assist business Capability Groups in developing and maintaining customer training programmes and help deliver training within area of expertise

• Deputize for Head, Third Party Programme Management, CQA and take on delegated duties as required

Why you?

Basic Qualifications:

• Bachelor’s degree in related Health Science field or equivalent

• Broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance

• Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance

• Extensive knowledge of global, regional and national regulatory requirements and regulations

• Detailed knowledge of the drug development and clinical processes

• Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization

• Demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies

• Demonstrated experience interacting with regulatory agencies

• Ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively

• High degree of organizational awareness and working towards resolution with complex problems

• Demonstrated project management skills, prioritization and management of cross-functional activities

• Demonstrated ability for excellent verbal, written and presentation skills

Why GSK?

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 impact the health of 2.5 billion people around the world in the next 10 years.

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.

• Li-GSK

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.

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