The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at the GSK Ware Manufacturing Site. This entails monitoring all quality related systems, improvement procedures and documentation (including data and information), ensuring that products released have been manufactured, packaged and distributed according to all Regulatory and cGMP requirements (including appropriate certification for EU markets).

Job Purpose:

Reporting to the Quality Standards Manager, the Quality Specialist manages a range of key Quality Systems to ensure the Quality Management System (QMS) requirements are in-place, in-use and effective (and creating an environment of inspection readiness).

Key Responsibilities:

• Administer Quality Management System changes and embed into site procedures. Coach SMEs through the review process and challenge where necessary to ensure a robust evaluation has been performed before changes are embedded into local procedures.

• Help coach and train others to drive improved adherence to all QMS activities, supporting CAPA when required.

• Collate, analyse & interpret quality system metrics to highlight negative / positive trends, escalate where required and support governance.

• Act as the SME for key quality management systems, presenting to auditors / regulators as required. Use this knowledge to drive continuous improvement across Quality Standards to eliminate waste and silo mentality whilst improving compliance.

• Work with central functions to review Quality / Regulatory changes and ensure our site procedures are aligned. Coach SMEs through the review and update processes to ensure changes meet requirements and are performed in a timely manner.

• Support colleagues within Quality Standards to ensure other processes (PPRs, Site Master File etc.) meet requirements in full and within given timelines.

• Manage the site Internal Audit and Self Inspection processes ensuring they are focused on risk and driving a state of inspection readiness. Review regularly to ensure emerging risks, trends in deviations etc, are taken into account.

• Manage Quality Alerts / Bulletins and other key quality issues identified at other sites to ensure they are appropriately assessed, mitigated and risk managed.

• Participate in inspection readiness activities to drive a state of permanent inspection readiness across Quality Systems and site facilities. Support regulatory and internal inspections including control room activities, reviewing presentations / SMEs, CAPA generation / verification etc.

• Manage the activities associated with stability management to ensure activities are performed on time and in full such that the stability schedule is fully met.

About You:

As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has strong experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

About Ware Manufacturing Site:

We are co-located with our R&D colleagues and recently opened a new, state-of-the-art oral solid dose facility at Ware. At this location our scientists, technicians and engineers (from R&D and Global Supply Chain – GSC) work collaboratively together (using the latest technologies) to rapidly knowledge transfer and deliver GSK’s most innovative, medicines faster and more efficiently. On site we produce over 60 million respiratory inhalers each year with growing demand in future years. The site also processes Active Pharmaceutical Ingredient (API) for use both on site and other manufacturing sites in our network.

CLOSING DATE for applications: Wednesday 29th of January 2025 (COB).

Basic Qualifications:

• BSc in Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).

• Knowledge of current Good Manufacturing Practice requirements.

• Knowledge and application of Quality Management Systems (QMS).

Benefits:

GSK offers a range of benefits to its employees, which include, but are not limited to:

• Competitive base Salary

• Annual bonus based on company performance

• Opportunities to partake in on the job training courses

• Opportunities to attend and partake in industry conferences

• Opportunities for support for professional development/chartership

• Access to healthcare and wellbeing programmes

• Employee recognition programmes

• Hybrid (onsite/remote) working within GSK policies (post training period)

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | 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. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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.

Important notice to Employment businesses/ Agencies

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.