Senior Consultant - Clinical Quality Engagement Lead

Boston (Remote Option Available)


Halloran is looking for someone passionate about clinical quality for commercial-stage medical device, biotechnology, and pharmaceutical companies and is ready to lead clinical quality engagements with our clients. The ideal candidate will utilize their background and expertise in GDP and GCP quality management to lead clinical quality engagements and be a subject matter expert to 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:
  • Leads and manages quality engagements to ensure client and company goals are achieved.
  • Provides clinical quality consulting to medical device, biotech, and pharmaceutical companies, customizing the quality and compliance approach to meet the unique needs of our clients.
  •  Leads, manages, and performs the following consulting services:
    • Develop and lead initiatives, including Inspection Readiness Planning for Sponsors, Sites and Vendors, Gap Analyses and Remediation, Inspection Readiness Training and Coaching, and Mock Inspections
    • Lead Clinical Quality continuous improvement initiatives driving excellence in Sponsor Oversight
    • Work with clients to plan (including setting specific objectives) audits, set audit criteria, 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 Clinical Quality 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
  • Focuses equally on results (high-quality deliverable that meet objectives); process (use of logical and efficient processes to achieve results); and relationships (engendering the client’s trust and goodwill among team members)
  • May participate in the hiring, performance management, and career development of assigned employees

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 global regulatory requirements; e.g., GXP, and CAPA
  • Previous experience with mid to large size commercial companies
  • Up to 30% of travel- blend of onsite and remote client support

Characteristics of Top Performers
  • Excellent presentation, organizational, and communication skills
  • Ability to customize the quality and compliance approach to a variety of clients
  • Ambitious spirit and roll up your sleeves mentality
  • 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
  • Comfortable with ambiguity and adaptable to change
  • Ability to manage schedule and comfort with leading a team including senior-level support

     
Halloran Consulting Group | Senior Consultant - Clinical Quality Engagement Lead