Lead Consultant/Consultant, GMP Quality Assurance

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, GMP Quality Assurance to join its Quality Assurance practice area. In this role, you will utilize their background and expertise in GMP quality management to provide consulting expertise to clients in all stages of development. Be part of a growing team where you can provide clients with creative and just-right quality expertise. 

Role Responsibilities:
  • Ensure successful engagement scoping, execution, and delivery of client work.
  • Provide quality consulting to biotech and pharmaceutical companies, customizing the quality and compliance approach to the meet the unique needs of our clients.
  • Lead, manage, and perform the following consulting services to biotechnology and pharmaceutical companies:
    • Develop and lead Inspection Readiness initiatives, including Inspection Readiness Planning for Sponsors, Sites and Vendors, Gap Analyses and Remediation, Inspection Readiness Training and Coaching, and Mock Inspections.
    • Execute Quality Assurance (QA) tactical plans to meet Quality objectives and goals.
    • 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).
    • Serve as an interim Quality Assurance resource for Halloran clients, including gap analysis, quality system maintenance, training, and general quality consulting.
    • Review client Standard Operating Procedures (SOPs) for gaps and redundancies, designing revision plans to address gaps, streamline content, and improve compliance.
    • Work with clients to plan GxP audits, including setting specific objectives, establishing audit criteria, and developing audit agendas.
    • Conducts a variety of audit activities which may include but not be limited to, GxP vendor audits, clinical study specific audits (e.g. investigator site, TMF), and  internal process audits.
  • Up to 35-50% of travel- blend on onsite and remote client support.
Education and Experience Requirements:
  • Bachelor’s Degree in life science or similar field.
  • Combination of 8-10+ years in Clinical Development and Quality Assurance in a variety of different settings.
  • Deep understanding of regulations, GxP, and industry standard practices.
  • Experience in all areas of quality with depth in GMP
  • Demonstrated experience with GMP auditing.
  • Auditing Certification desired
  • Previous experience with small and growing biotechnology and pharmaceutical companies.
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 detailed oriented.
  • Strong sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • 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 - Lead Consultant/Consultant, GMP Quality Assurance