Director Clinical Quality Assurance

Job title : Director Clinical Quality Assurance
Location : Cambridge
Job type : Permanent
Salary : US$200000 - US$220000 per annum
Contact name : Darren O'Connor
Contact number : +1 (469) 962 1148
Contact email : darren.oconnor@seclifesciences.com
Director, Clinical Quality Assurance
Salary starting from $200,000
Medical, Dental, Vision
401k and annual bonus.

SEC Life Sciences have been engaged with a versatile, high-growth Immuno-oncology company
based in Cambridge.
We are utilising years of experience in small molecule and biologics to develop a new, innovative
and targeted approach towards developing transformative therapeutics for cancer.

RESPONSIBILITIES:
* Take ownership for the Quality organization and help to build a strong Quality mindset
within the organization.
* You should have an in-depth knowledge on GCP oversight related to the QMS / SOP's
* Experience working with CRO's and Clinical vendors.
* Act as the Clinical SME for the Quality organization, experience working with CAPAs and
providing strategic advice to stakeholders.

EXPERIENCE
* At least 7 years experience working in clinical QA (GCP).
* Knowledge of FDA regulations and ICH Guidelines.
* 3 years experience in a leadership capacity.bout this position please apply.