Job Description

PharmaLex is looking to expand its Quality Assurance consulting network!

Although qualifications will vary depending on the specific project, in general clients are looking to engage Quality Assurance Managers and Directors with at least 5 – 10 years of clinical quality experience working in a regulated FDA environment.

MINIMUM QUALIFICATIONS:

• At least 5-10 years DIRECT EXPERTISE WORKING WITHIN THE PHARMACEUTICAL OR BIOTECH INDUSTRY (required for all positions)

· Hands-on experience with quality management system (i.e. training, metrics, documentation management)

· Strong GCP experience, phase I-III

· Robust understanding of change control principles and work flow

· Strong background on Deviations, Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA) management

· Familiarity with documentation control practices, including writing and revision of policies, SOPs and work instructions

· Batch records review and approval for clinical and commercial products

· Compliance review experience (i.e. laboratory data review, product release)

· Aptitude for increasing efficiencies and improving processes

· Auditing experience preferred

·Experience with QMS and/or EDMS / QMS software preferred (i.e. Trackwise, MasterControl, Veeva Vault, etc)

LOCATION

· Massachusetts: Boston / Cambridge and surrounding areas

Company Description

PharmaLex is the largest global service provider of regulatory affairs, quality management and compliance, pharmacovigilance and development consulting, in the pharmaceutical and medical device industry. We specialize in effectively supporting all aspects of product development – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees. The PharmaLex team continues to expand within the US and globally.