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Associate Principal Consultant, GxP Quality

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 an Associate Principal Consultant to join its Quality practice area. As an Associate Principal Consultant, GxP Quality, you will be responsible for leading the development quality consulting business to ensure successful engagement, scoping, execution and delivery of client work. You will provide creative and strategic quality and compliance approaches to meet the unique needs of each client, acting as head of quality for the development-stage business, and leading and managing quality team members.

 

Characteristic Duties:

  • Lead the development quality consulting business to ensure successful engagement, scoping, execution and delivery of client work
  • Provide creative and strategic quality and compliance approaches that meet the unique needs of each client
  • Defines methodology for practice areas within their area of expertise
  • Establish timelines, quality objectives and set resource objectives for a project
  • Act as head of quality for the development-stage business
  • Oversee the following consulting services:
    • Serve as an interim Quality Assurance Head for Halloran clients, assuming all leadership aspects of the role within the sponsor/client organization
    • Establish and/or revise client Quality Management Systems
    • Develop inspection readiness initiatives, including inspection readiness planning for sponsors, sites and vendors, inspection readiness training and coaching, and mock inspections
    • Oversee and/or deliver GxP-related gap analyses and remediation efforts across small, growing, and large sponsor/client companies
    • Develop and execute Quality Assurance (QA) plans to meet Quality objectives and goals
    • Create of client Standard Operation Procedures (SOPs); review of SOPs for gaps and redundancies; design revision plans to address gaps, streamline content, and improve compliance
    • Work with clients to plan GxP audits, including setting specific objectives, establishing audit criteria, developing audit agenda, and documenting audit findings
  • Lead and manage quality team members to ensure client, employee, and company goals are achieved
  • Publish and speak at industry meetings; participate in professional consortia, working groups, etc. in one or more practice area(s)
  • Contribute to business development efforts, including the authoring of proposals for new client engagements, identifying business development opportunities in existing clients and educating clients on Halloran services, and utilizing consulting network to identify new clients, prospects and business opportunities
  • Other duties and responsibilities as assigned

 

Qualifications:

Required:

  • A Bachelor’s degree in life science or similar field and a minimum of fifteen years of experience in Clinical Development and Quality Assurance at a sponsor company
  • Post-graduate coursework
  • Deep understanding of GCP regulations

Preferred:

  • Previous experience with small and growing biotechnology and pharmaceutical companies
  • Experience and expertise in one of the following: PVQA, GMP, and/or GLP

 

Halloran Consulting Group, Inc. Perks:

  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Reimbursements for Health & Wellness Programs and Memberships
  • Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
  • Self-Managed PTO Policy
  • Commuter FSA Benefits

 

Notice:

Our company is committed to equal employment opportunity.  We will not discriminate against employees or applicants for employment based on any protected class including, but not limited to race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.

Associate Principal Consultant, GxP Quality

Halloran Consulting Group, Inc.
United States
Full Time
Senior Level Career (10+ yrs experience)
Bachelor's

Published on 06/12/2020