Consultant, Quality Assurance

Boston - Remote within U.S. Option Available

Halloran is looking for someone who is passionate about Quality Assurance (QA) for development stage biotechnology and pharmaceutical companies and is ready to execute tactical plans to meet Quality objectives and goals. The ideal candidate will utilize their background and expertise in Clinical Quality Assurance to drive our firm’s strategic quality auditing business and provide consulting expertise to clients. Be part of a growing team where you can generate, close, and manage consulting business, work collaboratively with cross-functional team members, and provide clients with creative and just-right quality expertise.  

Job Responsibilities
  • Conduct GCP audits, both domestic and international, including Site, Vendor, Process, TMF, Document, and mock BIMO inspections.
  • Develop audit agendas, conduct audits and document audit findings.
  • Conduct complex tasks across multiple QA Systems such as Standard Operating Procedure (SOP) management, non-conformance mitigation, Corrective and Preventative Action (CAPA).
  • Work effectively and collaboratively with cross-functional team members.
  • Write and revise SOPs according to time, resource, and quality objectives.
  • Support other gap analysis, process improvement, and quality support projects as needed.
  • May act as the QA team leader or interim manager on behalf of the client.
  • Maintain positive relationships with Halloran clients, prospective clients, and independent consultants.
  • Provide clinical quality assurance expertise to clients in the pharmaceutical, biotech, and medical device industries. 
  • Conduct other QA activities including Gap Analysis, Inspection Readiness, Process Improvement, and CAPA review. 
  • Assist in developing/revising training presentations.
Education and Experience Requirements
  • Bachelor’s Degree in life science or similar field.
  • Combination of 8-10 years in Clinical Quality Assurance in a variety of different settings.
  • Broad knowledge base with both a quality background and an understanding of practical implications for product development.
  • Auditing experience in at least one GxP discipline.
  • Auditing certificate is highly desired.
  • Experience in all areas of quality with depth in one or more- GCP, GLP, GMP.
  • Previous experience with small and growing biotechnology and pharmaceutical companies.
  • Up to 25-35% of travel- blend on on-site and remote client support.
Characteristics of Top Performers
  • Excellent presentation, organizational and communication skills.
  • Able to customize the approach to quality and compliance for a variety of clients.
  • Roll up your sleeve mentality and ambitious spirit.
  • Thoroughness and detail oriented.
  • Strong sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • Motivates team members; fosters and nurtures teamwork.
Halloran Consulting Group | Consultant, Quality Assurance