Warman O’Brien

Head of Quality Assurance

Cambridge, Massachusetts
Up to $220,000 basic
23 Jul 2021
22 Aug 2021
Full Time
Contract Type
Experience Level

We are looking for a Head of Quality to join a mid sized ever evolving biotech who have just got their first product commercialised. They are now requiring someone with a wealth of experience across GCP, GLP and GMP to implement a full quality framework and to build out a competent quality department.


The Role

You will be skilled at building Quality processes and have in-depth knowledge of current GCP/GMP/GLP practices. You will be the subject matter expert for all things quality and will partner with various departments to implement and develop standards, processes and procedures.


Key Responsibilities

Proactively assess quality issues and risks whilst acting as the SME for all major quality related requests.

Build and develop a quality framework whilst building out a best in class department.

Enable teams to be inspections ready and assist project teams in implementing CAPA’s.

Lead both domestic and international audits and assess the impact to subject safety and data integrity.


Experience required?

10 years experience of quality assurance across both GCP and GMP environments.

Ideally a background as an auditor

Broad understanding of international regulations

Experience with GxP systems, processes and procedures

Management experience is essential


What to do next?

 Please apply with an updated CV as soon as possible as my client is urgently looking to hire into this vacancy.