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368557 Clinical Quality Assurance Program Lead

In this role you will

• Implement and manage the QA audit programme for one or more clinical development projects/programmes; partner with clinical teams to ensure appropriate risk prioritisation, scheduling, and tracking of QA audits. Provide active support during root cause analysis and support CAPA development
• Implement and manage Quality Assurance Plans for all programmes where audit activities are performed.
• Generate compliance statements for the Clinical study report where audit actives have been performed as requested by the clinical teams
• Provide support in the co-ordination and management of Regulatory Inspection activities for applicable clinical programmes.
• 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. Provide support in the root cause analysis activities for any inspection findings identified and support the business in development of responses
• Coordinate, manage and/or lead investigations of significant quality issues, 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 communication of trends, risk identification, analysis and performance metrics from QA audit and all investigation and inspection activities within the business function and 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, regulations 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 GCP 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 experience

Closing Date for Applications: May 14th (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.

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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 and/or Clinical Quality Assurance
• Extensive knowledge of global, regional and national GCP 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
• Demonstrated project management skills, prioritisation and management of cross-functional activities
• 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.

Find out more: 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 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.

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 Ukdiversity.recruitment@gsk.com 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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