You have the chance to join an exciting, growing health care company that are looking to invest in new & innovative products as well as shaping new departments. This Quality Lead is a brand new position to this business & as part of a new department you will be involved in shaping the future of this team.
This is an entrepreneurial business that have created a great infrastructure across their sites. As they are passionate about being market leaders in terms of product range & quality, this Quality Lead position will be an integral part of their ongoing journey. You could be part of shaping their promising future.
As the Quality Lead you will be developing & maintaining quality processes, procedures & systems, enabling effective management of Quality Assurance activities for the introduction of new products.
Key responsibilities include:
Ensure that the introduction of new products is carried out in accordance with current regulatory guidelines and the relevant marketing and manufacturing authorisations, including the provision of Technical Agreements, approval of third party manufacturing sites and approval of supply chain routes.
- Support technical & method transfer projects and activities as required to ensure processes are transferred in compliance with current regulatory guidelines and expectations.
- Support the due diligence process by representing the Quality function and advising on Quality critical aspects of any product acquisitions, in licence or distribution deals.
- Be accountable for the quality decisions and actions for the projects they represent.
- Liaise as necessary with third party organisations to represent the Company interest and resolve Quality related issues.
- Provide technical support and expertise to projects as required.
- Maintain the appropriate level of Quality Assurance knowledge for all product platforms, to allow the efficient and effective commercialisation and due diligence & NPI.
- Work closely with other functions (e.g. Planning, Supply Chain Coordinators, NPI, External Warehouses, Internal Customers, etc.) to ensure product can be compliantly distributed to market in support of product demand.
- Ensure compliance with statutory duties, regulation and legislation, in particular understand the regulations of controlled drugs in transit and storage.
- Ensure compliance with GxP.
- To understand the nature, operation and strategy of the organisation and continuously drive for improvement.
- Support and develop other members of the Quality and Supply Chain teams, where required to ensure they have the appropriate skills knowledge and expertise for the current and future success of the business.
- Support the process of continuous improvement with the aim to reduce cost, improve quality and increase.
GLOBAL TRAVEL WILL BE REQUIRED AS PART OF THIS ROLE.
A Quality Professional with Pharmaceuticals experience & the following:
High level of understanding & interpretation of Global GMDP guidelines legislation (EU, FDA).
- GMDP auditor would be beneficial
Working and/or practical knowledge in a range of manufacturing processes (preferably including biological/biosimilar).
Experience of working with external manufacturers.
Continuous Improvement methodology and approach.
Preferentially (not essential) Tech transfer & method transfer experience.
Project management/orgainsation skills.
Circa £50,000 - £57,000 + Benefits