Quality Assurance Manager

North London
£65000 - £75000/annum competitive
06 Jul 2017
05 Aug 2017
Contract Type
Full Time
A global pharmaceuticals manufacturing business is currently looking to hire a Quality Assurance Manager, Projects, to provide full GMP and Quality Assurance leadership to all projects at their state of the art new facilities based in North London.

Specifically the Quality Assurance Manager will take the lead on all capital and engineering projects and changes, manufacturing process improvements, and validation and commissioning projects across the site and be responsible for the QA Projects group team. The key task will be to ensure a harmonised strategy across all areas by managing multi-functional QA departments and projects. You will report into the Quality Director and will deputise for them when required.

Key tasks and responsibilities:

* Full Quality oversight, input and approvals to capital and engineering projects and validation and calibration activities for the GMP manufacturing plant
* In partnership with site engineering, operations and validation teams oversee and approve the preparation of technical and manufacturing documentation and assess compliance with the appropriate regulatory and company standards.
* Ensure lean and efficient business processes are established and maintained for all key quality business processes.
* Organisation of work plans to support all projects across site - ensure that approval, review, revision and distribution of GMP documentation supports agreed project timelines.
* Review and approval of changes to equipment, processes, utilities and plant.
* Participate in, and where necessary lead, risk assessments, change control assessments and investigations.
* Management of small group of Quality professionals (2-3 persons), including contract staff.
* Develop and maintain capability of QA Project Team to ensure support all projects, including recruitment of specialist contract staff as required.
* Deputise for Quality Director as required.


* 5 years' experience in pharmaceuticals in a Quality or Operational role ideally in a sterile environment.
* Strong technical skills with experience of validation and commissioning in sterile environment
* Strong leadership, management and technical skills.
* Good knowledge of cGMPs for steriles and preferably biologics
* Demonstrated success and leadership of multifunctional and multi-site teams.

This hugely commercially successful business has grown its output and turnover rapidly year on year and is now expanding to grow a network of customers internationally. Each department is evolving and the business promotes a culture of innovation and entrepreneurial attitude so is always looking to promote quickly internally and hire someone who is driven, ambitious and embraces change.

The salary on offer for the Quality Assurance Manager is £75,000 + good benefits package.

Please apply by the link provided or contact James Ivall at Real Staffing if you would like more information.

Hope to hear from you soon.

Sthree UK is acting as an Employment Agency in relation to this vacancy