Job Description
•
At least 3 years experience in the Pharmaceutical Industry and or Medical Device
Industry with an in-depth knowledge of US, EU and International regulatory standards, and
GxP Guidelines for the conduct of clinical trials.
•
Five plus years working in a Quality Control / Assurance area.
•
Experience and knowledge of medical device Quality System Regulations or ISO
Standards.
•
ASQ, Auditor, Clinical Trial Associate or Clinical Trial Manager accreditation highly
desirable.
•
Experience including external/CRO, clinical/regulatory and document auditing highly
desirable.
Spaulding Clinical Research management has the discretion to hire personnel with a
combination of experience and education which may vary from the above listed skills
and qualifications.
Spaulding Clinical Confidential
3
Clinical Quality Assurance Manager