Quality Standards Director
Site Name: UK - Hertfordshire - Ware
Posted Date: Mar 14 2023
Quality Standards Director
Location: Ware, UK
To ensure that the standards within general Quality Management Systems and other operational activities as recognized by Regulators are effectively translated, in place and in use across the site. Manage the quality & regulatory aspects of product lifecycle for new and established products.
Find out more:
- Lead and effectively manage diverse Quality teams responsible for Internal Business Monitoring, Management Monitoring, Quality/Regulatory Intelligence, the QMS, NPI Quality/MPD Quality Workstream Lead, Regulatory Conformance, TTSs, Stability Management, PPRs and third-party inspection management.
- Provide clearly defined Quality expectations for new products and processes emerging from the R&D pipeline to ensure that they are robust, correctly specified, and fit for purpose by driving a Quality by Design philosophy and providing/developing Quality expertise and appropriate Quality standards for new technologies and novel equipment installed at site.
- Provision of the site approval for new regulatory submissions on behalf of the Site Quality Director
- Ensure that new regulations and QMS requirements are accurately translated into site procedures and in-use across Site. Include intelligence gathered from other sources to help build more robust processes and improve compliance.
- Maintain a state of permanent inspection readiness across Quality Systems and site facilities and ensure that inspection topics can be effectively presented as necessary. Organise and host inspections as required. Ensure PAI activity is actively planned and executed.
- Ensure there is a robust and effective internal audit process that drives increased compliance across site, which in turn supports the ‘inspection ready everyday’ philosophy.
- Manage key quality and regulatory compliance aspects of product lifecycle for new and established products across multiple markets and lead regulatory compliance activities across the site, including management of site licences, product variations and licence renewals
- Provide inputs to the Site Quality Council and NPI Governance forums such that decisions can be made, and actions taken. Escalate when appropriate to equivalent above Site forums seeking resolution and sharing best practice as necessary.
- Deputise for the Site Quality Director in their absence.
Closing Date for Applications: 28th March 2023 (COB)
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Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Scientific discipline (e.g. chemistry, microbiology, pharmacology)
- 10 or more years of pharmaceutical industry experience
- Experience with Clinical Good Manufacturing Practices, FDA and other regulatory requirements
- Project management experience
- Team leadership experience is a must
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Demonstrate initiative analytical problem-solving skills
- Ability to use and interpret data to drive decision making at both a tactical and strategic level
- Ability to be flexible, adaptable, and a strong team player
- Foster teamwork and promote GSK values, behaviours, and strategies
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.
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