Director, Regulatory Data

2 weeks ago

Worthing West Sussex, United Kingdom GlaxoSmithKline Full time

Site Quality Director
This position provides quality leadership to ensure to ensure that the site operates in a sustained state of cGMP control and that products are released only when demonstrably compliant with cGMP and marketing authorisations.
The position holder is accountable to maintain an effective management oversight on Site Quality through having in place an effective QMS and a competent site Quality team to help them drive continuous improvement and standards at the site. They will be a member of the SLT and therefore be responsible for leading site quality decisions and influencing stakeholders at both site and a global level.
To approve or reject starting materials,packaging materials, and intermediates, bulk and finished products.
Ensure all necessary testing is carried out and associated records evaluated.
Effectively deploy the GSK Quality Management System (QMS) across all site operations and maintain audit process to demonstrate that it is sustained in use.
Staff, organise, train and develop a site Quality team to ensure that the responsibilities of the Quality Unit are effectively discharged and that adequate succession exists for key roles.
Maintain the site in a state of continuous cGMP compliance, sustaining fully compliant QA/QC operations specifically. Interact proactively and effectively with external Regulatory Agencies, managing site inspection events to satisfactory outcomes.
Effectively sustain those Quality and compliance governance processes required by the QMS, e.g. Quality Council and PIRC processes.
Ensure that process and product quality related investigations are diligently performed, root causes established and effective CAPAs brought into place and use.
Robustly represent the Quality and compliance function agenda within the Site Leadership Team and engage team members in promoting and driving an effective site Quality culture.
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. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge
Considerable Quality experience in pharma industry or process deveopment environment (manufacturing, quality control, quality assurance, distribution) including GDP
Second degree in a physical, biological science or Qualified Person eligibility.
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 continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. 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 automation and robotics so we can work smarter together.
*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).
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. recruitment@gsk.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. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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.
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