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:

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Key Responsibilities

• 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)

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 0[Register to View] . This will help us to understand any modifications we may need to make to support you throughout our selection process.

*LI-GSK

Why you?

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.

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 [Register to View] or 0[Register to View] . 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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