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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 analytical 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).

We now have 3 vacancies in the Customer Complaints & Supplier Quality function:

• Quality Manager (Grade 8) – 12-month Fixed Term Contract (FTC)
• Quality Co-Ordinator (Grade 9) – Permanent Role
• Quality Co-Ordinator (Grade 9) – 12-month Fixed Term Contract (FTC)

Quality Manager - Job Purpose:

Reporting to the Supply Quality and Customer Complaints Manager, you will manage site-based supplier quality operations to ensure materials being delivered to site are of the appropriate quality. You will be responsible for managing/approving customer complaints to ensure complaints are investigated and reported in line with regulatory requirements.

Key Responsibilities:

• Act as the key liaison between the Ware site and assigned suppliers, incorporating central supplier quality, procurement and audit teams as required, for supplier quality matters. Where change controls are required, coordinate the on-site activities for supplier and outsourced service provider change controls.
• Assess new and existing suppliers / service providers via desktop assessment or audit to ensure they are suitable to carry out activities.
• Investigate and manage vendor complaints, including informing the supplier; ensuring they understand and accept the issue; working with them to address root causes; generating effective CAPA and confirm acceptability of supplier responses.
• Approve component specifications, supplier agreements, service level agreements etc. in consultation with relevant departments and suppliers (inc. TTS, PRS, DRA etc.)
• Collate and review supplier quality history data and prepare reports to determine level of acceptability based on risk. Collate data required for inclusion on PPRs.
• Assess critical metrics for suppliers and ensure written agreements in place for outsourced activities covering required GMP requirements and that these are reviewed according to required schedule.
• Approve Customer Complaint responses and assess atypicality. Escalation of atypicality to stream Operational Quality. Tracking completion of complaint investigations to meet required timelines.
• Progress Customer Complaint investigations including logging complaints, monitoring of progress, assessment of findings and documentation of outcomes.
• Act as SME/inspection lead for Supplier Quality management or Customer Complaints during internal and external audits ensuring that processes are robust and inspection ready at all times. Lead self-inspections.
• Work alongside central functions (Procurement, Global Supplier Quality, Logistics etc.) by supporting requests such as pre-audit info, supplier quality performance reviews etc. Ensure any site issues are escalated through such teams to drive resolution.

Quality Co-Ordinator - Job Purpose:

Reporting into the Supplier Quality & Customer Complaints Manager, you will mainly support the Ware manufacturing site by managing the handling of complaints reported for products manufactured at the site, to ensure they are investigated and reported thoroughly and in line with regulatory and corporate requirements. Working in a multi-disciplined team, you will also have opportunities to support the supplier Quality Management site-based activities.

Key Responsibilities:

• Performing preliminary complaint analysis and engagement of the appropriate business area to carry out further investigation.
• Logging complaints, monitoring of progress, assessment of findings and documentation of outcomes.
• Investigation, documentation and co-ordination of vendor complaints, including: informing the supplier; ensuring they understand and accept the issue; working with them to address root causes; generating effective CAPA and confirm acceptability of supplier responses.
• Arranging reject batches to be returned to suppliers or to be written off by liaising with logistics and key stakeholders.
• Reviewing supplier quality/purchase agreements for materials in consultation with relevant departments and suppliers.
• Interacting with the above site groups including Global Supplier Quality and Procurement, by supporting ad hoc requests, for example providing pre-audit information.
• Collation of supplier quality and customer complaints information for inclusion into quality documents, for example Periodic Product Reviews.
• Coordinating the on-site activities for supplier and outsource supplier change controls liaising with central functions, suppliers and impacted departments.
• Participating in internal audits and external audits for Supplier Quality and complaints management.

Please Note: 12-month Secondments – Please note that currently the secondments are expected to last circa 12-months in duration. Please ensure you have spoken with your line-manager to ensure they are supportive of your application (this includes a timely-release from your current responsibilities should you be offered the Secondment).

About You:

As this role is multi-faceted and includes liaising with a wide variety of on-site production teams, above-site stakeholders and external suppliers you will be a self-motivated individual who has 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 objectives 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.

CLOSING DATE for applications: Friday 27th of January 2023 (COB).

When applying for this role, please use your CV to describe how you meet the competencies for this.

Basic Qualifications:

• Graduate qualification or equivalent experience ideally gained working in a Pharmaceutical Manufacturing Facility.
• Knowledge of current Good Manufacturing Practice requirements within major pharmaceutical markets.

About GSK:

GSK has changed. In July 2022, we demerged our world-leading consumer healthcare business, Haleon. We are now a fully focused biopharma company. We prioritise innovation in vaccines and specialty medicines, maximising the increasing opportunities to prevent and treat disease. At the heart of this is our R&D focus on the science of the immune system, human genetics and advanced technologies, and our world-leading capabilities in vaccines and medicines development. For more information on GSK please refer to our website: www.gsk.com

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 [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

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