Senior Consultant - Development Quality

Boston or California


Halloran is looking for someone who is passionate about quality assurance for development stage biotechnology and pharmaceutical companies and is ready to lead a growing team of quality consultants. The ideal candidate will utilize their background and expertise in GMP, GLP, and/or GMP quality management to drive our firm’s strategic quality business and provide consulting expertise to clients. Be part of a growing team where you can generate, close, and manage a consulting business, lead and manage others, and provide clients with creative and just-right quality expertise.  

Job Responsibilities

  • Manage quality consulting business to ensure successful engagement scoping, execution, and delivery of client work
  • Lead and manage quality team members to ensure client, employee, and company goals are achieved
  • 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

Education and Experience Requirements

  • Bachelor’s Degree in life science or similar field
  • Combination of 8-12+ years in Clinical Development and Quality Assurance in a variety of different settings
  • Deep understanding of regulations, GXP, and CAPA
  • Previous experience with small and growing biotechnology and pharmaceutical companies
  • Up to 25% of travel- blend on onsite 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 sleeves mentality and ambitious spirit
  • Thoroughness and detailed oriented
  • Strong sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
  • Motivates team members; fosters and nurtures teamwork

 

Senior Consultant - Development Quality