Quality Assurance Consultant

Quality Assurance Consultant

Job Location: Boston, MA

Job Scope & Purpose

Our small Greater Boston biotech client is seeking a Director/Sr. Director level Quality Assurance Consultant whose responsibilities will encompass all aspects of Quality Assurance. This is a long-term, full time need with availability to convert to a permanent position.

Primary Job Responsibilities:

Perform a wide variety of activities to ensure compliance with applicable regulatory requirements

Expand and maintain phase-appropriate Quality Management Systems

Ensure overall Quality & Compliance oversight for manufacturing, nonclinical, and clinical activities

Improve and maintain internal Quality Systems training program

Develop and maintain internal and external audit programs for GxP activities leveraging internal resources and contract auditors

Implementation and validation of Electronic Quality Systems

Plan & oversee day-to-day activities of the Quality function

Primary Job Requirements:

BS/BA degree with 10+ years of Quality Systems experience in Biotech and/or Pharma; Advanced Degree a plus

Extensive experience with GxP and ICH

Experience working in small/mid-size biopharmaceutical companies and experience working within a virtual manufacturing model

Demonstrated experience in execution and management of deviations, OOS/OOT, CAPA, internal and supplier audit programs, and quality system maintenance