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Job Title

Compliance Specialist

CLOSING DATE: 30th May 2023

GSK make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2022.

We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.

We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.

The Compliance Specialist will ensure that the site complies with cGMP, the GSK Quality Management System and all compliance requirements as well as manage the site’s Management Monitoring audit program and Change Control process.

In this role you will…

• Own and manage the site change control process for all quality impacting changes. Ensure all targets are met, performance tracked and communicated as required.
• Manage the site management monitoring audit program ensuring delivery of cGMP compliance, QMS “in place” and “in use” expectations to deliver inspection readiness. Manage the Level 1 Auditor Certification programme on site and maintain capability via training, mentoring, and coaching.
• Carry out verification of audit CAPA, as required to ensure these are “in place”, “in use” and effective.
• Manage the Quality Alert / Quality Bulletin / Quality Regulatory Intelligence processes
• Manage the QMS implementation process ensuring that all QMS documents are assessed regarding QMS applicability and deployment. Provide support, training, coaching for site personnel as well as partnering with the Central Group as required.
• Drive and improve the compliance culture to ensure audit readiness via coaching, mentoring, and training.

Why you?

Qualifications & Skills:

• HND in a relevant subject or suitable extensive experience in an appropriate discipline within a pharmaceutical environment
• Good influencing, communication, and coaching skills
• Experience in resolving cGMP / compliance issues
• Experience in internal or external audits

Preferred Qualifications & Skills:

• Science Degree or equivalent
• Trained in auditing at Level 1 / 2 to a standard equivalent to GSK expectations
• Experience in use of SAP systems, M-ERP and/or Quality Documentation systems would be an advantage

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 positively impact the health of 2.5 billion people by the end of 2030.

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

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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