Warman O’Brien

Quality Assurance Manager

Boston, Massachusetts (US)
Up to $150,000 basic
23 Jul 2021
22 Aug 2021
Full Time
Contract Type
Experience Level

We are looking for a highly driven, Quality Assurance Manager to be responsible for GCP activities for a fast growing biotech who are currently breaking ground with their innovative portfolio of products currently making their way through clinical trials.

This will be the primary QA role within the organisation and so you will be best placed to build out the Quality Assurance function.


The Role

As the Quality Assurance Manager you will be responsible for internal and external GCP audits, deviations, and ensure CAPAs are documented and remediated in compliance with internal procedures and applicable regulatory requirements. You will support clinical inspection readiness and develop SOP’s to ensure compliance.


What can you bring?

 ·       At least 5 years of quality assurance experience

·        Solid understanding of GCP regulatory compliance and auditing experience

·        Excellent communication skills, alongside the ability to build, influence and maintain relationships.

·        Demonstrated critical thinking with strong project co-ordination skills.

·        High level of resilience with ability to work under pressure


What do you get in return?

 ·        You will be working in a great team who have a culture of collaboration and teamwork.

·        The opportunity to work in a fast growing environment with plenty of opportunities to progress

·        Flexible and dynamic working environment and the chance to truly build out a brand new department.


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.