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Compliance Lead - Irvine, United Kingdom - GSK

GSK

Verified Company

Irvine, United Kingdom

4 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Site Name:
UK - North Ayrshire - Irvine

Posted Date:
Feb

We 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 1.7 billion packs of medicine and 767 million vaccine doses in 2021.

We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service.

The way we work will change. For some, the shift in technology and products will be revolutionary.

Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

Compliance Lead
As the Compliance Lead you will be part of the Quality leadership team.

You will play an active role in driving a strong Quality culture, mentoring and coaching your team and the site in areas such as Data Integrity.

You will also ensure the site maintains compliance with our company Quality System, leading your team in utilising technology and working with users across all departments in the implementation of effective processes to deliver this.

This is a great role that provides strong development and progression opportunities.

You will be required to work at the Irvine site, however there is remote working flexibilities when business permits.

Job Purpose

Responsible for partnering with Quality and Site Leaders to ensure that all compliance activities and cGMP standards are met to support the business requirements.

In this role you will

Understand and manage the Compliance, Quality, and cGMP standards and contract with all customers to ensure and deliver these requirements.
Lead and manage the site internal and Regulatory audit programme including ensuring agreement of effective CAPA anddriving action completion to deliver the site's continued adherence to cGMP.
Lead and manage the site Inspection Readiness Programme to ensure that the site maintains a state of inspection readiness.
Drive continuous improvement and eliminate waste associated with relevant compliance processes and procedures within the Compliance Team using Operational Excellence principles.
Own the Document Lifecycle Management process and ensure that filing and storage of cGMP documentation is carried out and is compliant with internal and external expectations.
Lead and manage the site risk management process, acting as site Risk Management Process Owner. Chair the Site Risk Management Compliance Board and Quality Risk Review Forum and have responsibility for the Quality Risk Matrix.
Own and manage all aspects of the site Change Control process.
Lead the Data Integrity programme at Irvine and drive improvements in the associated culture to ensure delivery of the current data integrity standards. Develop and coach the team, wider department and site to ensure strong understanding and appreciation of compliance expectations, including Data Integrity.
Manage the process for ensuring that department training packages are maintained to the expected standard and are current.
Management and oversight of the Pest Control Process.

Closing Date for Applications:

Sunday 12th March 2023:
Please take a copy of the Job Description, as this will not be available post closure of the advert.

LI-GSK

_ Why you?_

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Suitable extensive experience in an appropriate discipline within a pharmaceutical environment.
Experience in interpreting regulatory expectations and QMS.
Strong influencing, communication and coaching skills.
Experience in resolving cGMP / compliance issues.

Preferred Qualifications:

Experience in leading / managing teams

_ Why GSK? _

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 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. Wher