Senior Consultant, Development Quality

Boston (Remote Option Available)

 

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 GCP, 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 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 12-14+ 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 one or more- GCP, GLP, GMP.
  • Previous experience with small and growing biotechnology and pharmaceutical companies.
  • Up to 25-35% 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 sleeve 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.

 

Halloran Consulting Group | Senior Consultant, Development Quality