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360139 Regulatory Inspections and Investigations Lead, Clinical Quality Assurance

The purpose of this role will be to provide effective management of GCP Regulatory Agency Inspections and Issue Investigations as well as lead study and functional teams as a subject matter expert for the preparation, conduct and response to GCP Regulatory Inspections.

The successful candidate will also lead cross-functional teams to fully investigate serious compliance concerns, analyze results and agree appropriate and proportional actions to address and be responsible for monitoring compliance trends from inspections and investigations; and accountable for driving quality system improvements and ensure compliance.

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

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Our approach to R&D

In this role you will

• Support the development, management, and implementation of processes, associated written standards and job aides to support effective management of Regulatory Inspections and Issue Investigations across GSK R&D Development
• Coordinate and manage Regulatory Inspection activities for GCP process inspections both centrally and at Local Operating Companies. Serve as the main point of contact for inspection preparation partnering with risk managers to ensure business functions are prepared for both national and local inspections (FDA, EMA, MHRA, etc.). Ensure identification and mitigation of known quality issues and potential GCP compliance risks. Lead root cause analysis activities for any inspection findings identified and support the business in development of responses.
• Support the delivery of Regulatory Inspection activities for clinical programmes in partnership with the applicable CQA Programme Management Lead. Provide subject matter expertise to ensure effective inspection management.
• Provide proactive and regular communication of trends and performance metrics from all investigation and inspection activities across R&D 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 and guidelines; and the impact to business area processes and procedures. Additionally ensure intelligence is utilised for continuous improvement of inspection management processes.
• 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. Assist in developing and maintaining customer training programmes and help deliver training within area of expertise.
• Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility.

Closing Date for Applications: February 12th, 2023 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

• LI-GSK

Why you?

Qualifications & Skills:

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

• Bachelor’s degree in related Health Science field or equivalent.
• A 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
• A demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies
• Demonstrated experience interacting with regulatory agencies
• The ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively
• Must have a high degree of organizational awareness and working towards resolution with complex problems
• Have demonstrated project management skills and management of cross-functional activities
• Have demonstrated ability for excellent verbal, written and presentation skills

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. 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.

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Annual Report 2021

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 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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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