Quality Regulatory Excellence Director (GSK)

Job Description

Quality Regulatory Excellence Director

This role can be based at GSK commercial manufacturing sites across the UK, Europe or US.

This is a truly exciting position for the Quality Regulatory Excellence Director to Deliver on regulatory conformance processes and activities across GSK’s medicine and vaccines manufacturing sites and External Supply network. This role will provide a central focus and drive for continuous improvement, building capability, and driving harmonization in accountability and function across regulatory conformance teams.

In this role you will:

• Serve as the accountable GSK Quality lead for regulatory conformance business processes, risk and issue management, and continuous improvement for sites, external supply, and LOCs.
• Develop and implement efficient business processes for managing regulatory information, including regulatory change control management, to support SKU management and batch release.
• Define and implement GSC strategies to meet new country requirements, such as additional testing in Korea and site data for Kenya.
• Lead regulatory conformance activities for sites and external supply to support compliance and improvement projects, including training curricula development, remediation programs, and data integrity initiatives.
• Chair the GSC Regulatory Conformance Community of Practice and Steering Team.
• Enhance site capability for regulatory conformance, disseminate knowledge of global regulations and guidance across the network, and trend key performance indicators for regulatory conformance business processes.

CLOSING DATE for applications: 6th November 2024

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

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.

Required qualifications and skills:

• Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge
• Significant regulatory compliance experience in medicines/vaccines manufacture and release
• Detailed knowledge of global regulations and guidance, global regulatory expectations, industry standards and risks pertaining to regulatory conformance processes.
• Excellent understanding of Pharmaceutical Quality Systems and QMS
• Considerable quality experience in pharma industry or process development environment (manufacturing, quality control, quality assurance, external supply)
• Demonstrated experience managing and improving quality systems, including project management elements
• Proven experience interfacing and influencing senior Global Leadership team stakeholders
• Strong leadership skills
• Ability to lead cross functional project and/or matrix teams to an aligned strategy

Preferred qualifications and skills:

• BA/BS or Masters Degree
• Excellent oral and written communication skills
• Excellent interpersonal skills, including the ability to interact/influence/negotiate effectively at all levels of management and peers.
• Deep knowledge and experience in operational excellence / continuous improvement techniques and deployment
• Experience and comfort working with digital systems

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023. 

We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

If you are interested in joining us, find  out more:

Annual Report 202JOB IS FROM: italents.netVIEW3

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.

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.

*LI-GSK

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.

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. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

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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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.