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 Laboratory Manager, the Laboratory Compliance Lead provides subject matter expertise to support the achievement of regulatory and business strategies by ensuring effective line management processes and plant.  The role’s responsibilities extend to embedding governance standards and capability development to ensure Safety, Quality and Efficacy are built into all laboratory compliance activities.

Operational Quality – Please note that this is a site-based role, aligned to support across the Ware manufacturing site.

Key Responsibilities (include..,):

• Leading and owning the Laboratory Quality council meetings (as well as attending Quality council as Lab Manager delegate when required).

• Managing Laboratory L4 audit action and CAPA (including tracking audit actions to completion for the Laboratory).  Acting as Laboratory audit host for L2 3 and 4 audits.

• Ownership (maintenance) of key quality compliance process such as change control, risk and management monitoring

• Managing Compliance Governance, ensuring that Compliance Dashboard targets are met, L1 Quality inspections and resulting actions are complete, EHS Audits, Risk Assessments, ZAPs and resulting actions are managed.

• Ownership of a Compliance Business process on behalf of the laboratories (e.g. SOP/SWI, Laboratory worksheets, Risk Assessment) including training of Staff in these processes.

• Adopting best practice Compliance initiatives such as Inspection Readiness and Living Safety. This will include supporting site process owners to deliver improved standards within the stream.

• Implement changes to Quality, Safety and Compliance Processes to better support the site's NPI Role.

• Planning of Compliance activities typically 3-12 months with strategic perspective of 1-2 years and embedding processes which continually manage compliance task demand.

As part of the quality assurance team, you will actively promote team working and effective communication across the Ware site and across GSK’s wider Quality functions (at other sites).

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 laboratories across 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:

Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms.

CLOSING DATE for applications:  Monday 2nd of September 2024 (COB).

Basic Qualifications:

• Relevant qualifications (eg; BSc in Scientific discipline or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).

• Relevant experience (eg; Use of the DIA model, managing a variety of complex compliance processes, and understanding of the regulatory bodies and requirements).

• Knowledge / understanding of laboratory compliance processes.

• 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 [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. 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 .

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