Director Clinical Quality Assurance

Job title : Director Clinical Quality Assurance
Location : Cambridge
Job type : Permanent
Salary : Negotiable
Contact name : Megan Siggins
Contact email : megan.siggins@seclifesciences.com
Director, Clinical Quality Assurance (GCP)

SEC Life Sciences are engaged with a rapidly growing biotech, working on developing medicines targeting serious diseases in Cambridge, Massachusetts.
Off the back of the extremely successful year they have had, they are looking to expand their Clinical Quality team in 2023. They are planning a commercial launch in the new year and are looking for someone to come in and provide great GCP background knowledge with teams across the company.

Responsibilities:
* Relied upon as the Subject Matter Expert in GCP compliance in relation to Clinical studies.
* Act as GCP QA lead- ensuring overall study compliance.
* Working alongside the internal Vendor Audit Manager to ensure successful execution of GCP Vendor audits.
* Support the growth of the Clinical Quality Assurance team.

Experience
* 5+ years' experience working in clinical QA (GCP).
* Have an in-depth knowledge of FDA regulations and ICH guidelines.
* Previous management experience.
* Experience in working in a small company is preferred.

How do I apply?
Apply directly here, or send a copy of your resume to megan.siggins@seclifesciences.com