QA Regulatory Manager
We have an exciting opportunity to join the quality team here at GSK Worthing on a Fixed Term Contract (FTC) until the end of July 2019. We are looking for inspired individuals to support us in our mission to help people Do More, Feel Better and Live Longer.
The QA Regulatory Manager is responsible for maintaining current regulatory documentation for all Worthing site processes responding to changing business and regulatory agency requirements. In this role you will provide expert regulatory knowledge to the site to ensure continued licence compliance and successful implementation of projects.
Your Key Responsibilities focus on:
• Lead the maintenance of site compliance to licences/ pharmacopoeias and worldwide regulatory requirements.
• Manage the preparation and review of submissions for variations/supplements for all Worthing site products.
• Liaise with Global Post Approval Regulatory Affairs to review questions from global regulators and provide and agree official responses.
• Provide expert regulatory advice critical to the development and implementation of strategic projects and for ongoing production batch destination.
• Approve Technical Terms of Supply and Technical Agreements with global markets and 3rd parties.
• Lead the setting and registration of appropriate specifications for all site products.
• Provide regulatory support for Level 3 and 4 audits.
• Management of the site regulatory team and budget.
Please note this role will be based at our site in Worthing West Sussex. At Worthing, our focus is to manufacture and supply the broad-spectrum antibiotic, Augmentin as oral tablets, suspensions and sterile injectable dose forms. Worthing Site is a mixed manufacturing site with complex regulatory pressures. Manufacturing processes are highly technical and include high hazard activities.
The successful candidate should have a degree in a scientific or engineering discipline or possess demonstrable equivalent experience.
You will also have:
• Comprehensive knowledge of worldwide regulatory requirements and current standards and formats
• Comprehensive knowledge of operations in areas of expertise, e.g. steriles, packaging, manufacturing,
• Understanding of mechanisms involved in Pharmacopoeial monographs/test methods and General Notices
• Awareness of the regulatory requirements of change and impact on business processes of delays
• Good knowledge & understanding of the QMS and change control system in particular.
• Computer Skills - Excel/PowerPoint/Word.
• Strong listening skills, analytical ability to diagnose problems, planning and management skills and the ability to develop practical solutions.
• Excellent communication skills, both interpersonal and presentation; able to interact with and influence all levels of individuals across a variety of organizations (without a direct reporting relationship).
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
What's on offer?
• A competitive base salary with an annual bonus that rewards you for your individual contribution to our strategy, as well as business targets.
• Benefit programmes designed to support you and your family, including access to healthcare and well-being programmes, pension plan membership, savings programmes, time off and childcare support.
• Employee recognition programmes which reward exceptional achievements.
• Share ownership schemes which link your reward to GSK's longer term performance
• A performance and development programme that helps you identify what you need to do, and the behaviours you need to demonstrate, to achieve success
Interested in join the team?
Closing date for applications: COB - Friday 22nd June 2018
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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