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

We have multiple job opportunities in Biotech/pharmaceutical industry.
If interested respond back with your most updated resume to evelyn@pragna.net