QMS Lead (Biopharmaceuticals)

Recruiter
Anonymous
Location
London
Salary
50000.00 - 65000.00 GBP Annual + GBP50000 - GBP65000/annum Benefits
Posted
10 Feb 2017
Closes
25 Feb 2017
Function
Consultant
Contract Type
Permanent
Hours
Full Time
QMS Lead (Biopharmaceuticals)
GBP50,000 - GBP65,000 + Benefits
Based in London

Do you have a background in QMS authoring, implementing and management?

Would you like to help establish and grow a brand new, cutting-edge Gene Therapy company in London?

My client are a clinical stage Gene Therapy company with a strong and varied development pipeline. Working in a Key Quality Assurance role, reporting to the Head of Quality, the QMS Lead will be responsible for supporting the implementation of quality management systems and ensuring that the company is following EU and FDA GMP, ISO9001 and any other applicable regulations in the pursuit of their goal to become a world leading Gene Therapeutics company.

This role is to ensure compliance to the Quality Management System and support the Head of Quality where required.

The position has 1 direct report, the post of Documentation Controller.

Responsibilities will include;

* Authoring, Implementation and Management of the company Quality Management System (QMS)
* GMP document Management, including Document Control
Generation, Review and approval of relevant GMP documentation.
* Management of the of deviation, investigations, change controls and CAPA
* Responsible for status control of products/material
* Assure compliance to EU and FDA GMP protocols and any other applicable regulations/standards
* Assure compliance to MHRA regulations to ensure retention of MIA(IMP) and MS licenses
* Maintain QA KPI metrics
* Check operational documentation for completeness, accuracy and adherence to Good Documentation Practices, where appropriate Quality approving documentation
* Deputise for the Head of Quality as appropriate

To be considered for this role you will have the following skills & experience;

* Degree in Life Sciences, Human Health or other Science, or equivalent relevant work experience in the pharmaceutical, biopharmaceutical or other similar regulated industry (i.e. biologics, aseptic manufacturing or medical devices).
* Demonstrable experience in a quality management systems position in the pharmaceutical or other regulated industry, including authoring, implementing and managing the QMS.
* A track record in successful documentation control.
* The ability to disseminate best practise from a Quality Management perspective across a growing cutting edge technology company
* Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
* Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred.

Key Words "QA, Quality Assurance, QMS, Quality Management System, Pharmaceutical, BioPharmaceutical, Biologics, Documentation, GMP, GLP, FDA, MHRA, QA Manager, Quality Manager, Quality Lead"

Please apply online or call Neil Walton on

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency