Lead Consultant/Consultant, GCP Auditor

Boston - Remote within U.S. Option Available

 

Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!

Halloran is looking for a Lead Consultant/Consultant, GCP Auditor to join its Quality Assurance practice area. In this role, you will utilize your 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.

Role Responsibilities:
  • Conduct GCP audits, both domestic and international, including Clinical Investigator Sites, Vendors, System/Process, TMF, Document, and mock BIMO inspections.
  • Develop audit agendas/confirmation letters, 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)
  • Conduct other QA activities including Gap Analysis, Inspection Readiness, Process Improvement, and CAPA review.
  • Assist in developing/revising/delivering training presentations.
  • Work effectively and collaboratively with cross-functional team members.
  • Write and revise SOPs according to time, resource, and quality objectives.
  • Support other quality  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.
  • Contribute to development of proposals and successful engagement scoping
  • Identifies new business development opportunities
  • Utilizes consulting network to identify new clients, prospects and business opportunities
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.
  • Demonstrated experience with GCP auditing
  • Experience in all areas of GxP quality with in-depth in GCP, regulations, industry trends, health care / business practices in drug development; medical device experience is a plus
  • Previous experience with small and growing biotechnology and pharmaceutical companies.
  • Up to 35 - 45% 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, Inc. Perks:
  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Commuter Benefits
  • Reimbursements for Health & Wellness Programs and Memberships
  • Self-Managed Vacation Policy
Halloran Consulting Group l Lead Consultant/Consultant, GCP Auditor