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Job Title

Documentation Lead

CLOSING DATE: 30th June 2023

GSK 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 2022.

We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.

We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.

This is an exciting opportunity to lead Documentation standards at the Barnard Castle site. The Barnard Castle site is located in the North East of England within the County Durham countryside. Barnard Castle is a critical secondary site for GSK with a large number of New Products coming through development from R&D. We manufacture and supply a huge range of different pharmaceutical products from Sterile Biological and Small Molecule Products to Liquid Inhalations and Dermatologicals. We have recently opened a new state-of-the-art aseptic digital facility focussed on producing GSKs pipeline of new biopharmaceuticals.

The Documentation Lead will ensure all documentation at site is maintained in a compliant and standardised manner in accordance with the QMS Documentation Management and Control requirements. The site is the largest user of Veeva QualityDocs (VQD) in the network and it is critical to ensure documents that are created and maintained within the system are inspection ready and able to support successful external inspections. There are a number of other documentation systems in use at site and they also require oversight to ensure compliance with emerging and evolving standards including adherence to archiving and retention requirements.

In this role you will…

• Ensure compliance with all Quality Management System changes related to documentation practices, with a process in place to evaluate and embed these changes into all relevant site procedures
• Responsible for the site standard and control of SOPs
• Fronts audits and inspections regarding the documentation systems in use
• Coordinate with the Learning and Development team the training requirements needed for documentation processes
• Report any escalations to line management and where necessary, site Quality Council
• Support the business in defining corrective and preventive actions associated with observations and findings related to documentation from audits, which are subsequently tracked to completion through the Quality system
• Oversight of document storage and control of all documents in VQD, monitoring trends and creating dashboards to aid visibility / support performance management
• Use GPS to promote and embed a culture to assure daily inspection readiness of documentation processes
• Benchmark performance of documentation practices inside GSK
• Responsible for the management of documentation risks at site to ensure they are appropriately assessed, mitigated and risk managed
• Promote the Data Integrity Programme with respect to documentation practices
• Leadership of the site Archiving processes and ensuring an effective service is provided to the site
• Provide the site with a point of contact from central IT for VQD and for the site-based teams
• Conduct self-inspection audits of the VQD environment, ensuring appropriate access permissions are granted to all users and to provide assurance as to the conformance of site documentation processes to GXP and internal GSK Quality standards
• Ensure active participation in the Community of Practice for VQD.
• Lead the implementation of improvements in the VQD platform ensuring all items are appropriate, timely, fully communicated and completed to plan.
• Create system IT incidents tickets, as required, to resolve issues with VQD performance.
• Responsible for managing Restricted and External audience access to VQD.

Why you?

Qualifications & Skills:

• Quality, Compliance, and regulatory requirements
• Knowledge of QMS and Regulatory guidelines
• Pharmaceutical manufacturing
• Innovative and creative
• Ability to work well under pressure within tight timelines
• Interpersonal skills: Works well with others, able to champion new ways of working
• Analytical: Able to analyse complex data / information / scenarios and make rational, risk-based decisions
• Training and experience in Operational Excellence / LeanSigma / GPS
• Communication skills: Ability to articulate decisions or recommendations clearly and confidently
• QMS Gap Analysis and Implementation
• Experience with electronic document control systems
• Management of documentation within an electronic system as a Local Business Administrator
• Improvement experience to aid simplification of the processes involved

• Author of documents, especially Standard Operating Procedures and Standard Work Instructions

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 [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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