Consultant, GCP Quality

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 Consultant to join its Quality practice area. As a Consultant, GCP Quality, you will be responsible for providing clinical quality assurance expertise to clients in the pharmaceutical and biotech industries. Responsibilities include establishing project timelines, quality and resource objectives, managing Good Clinical Practices (GCP) activities, and providing other quality activities including Gap Analysis, Inspection Readiness, Process Improvement, and Corrective and Preventative Action (CAPA) review.

 

Characteristic Duties:

  • Establish project timelines, quality and resource objectives
  • Determine project methodology
  • Manage project team
  • Ensure successful engagement scoping, execution, and delivery of client work
  • Lead, manage, and perform the following consulting services to biotechnology and/or pharmaceutical companies:
    • Develop inspection readiness initiatives, including inspection readiness planning for sponsors, sites and vendors, inspection readiness training and coaching, mock inspections, and inspection response remediation
    • Execute Quality Assurance (QA) tactical plans to meet Quality objectives and goals
    • 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 GCP audits, including setting specific objectives, establishing audit criteria, and developing audit agendas
    • Conduct a variety of audit activities which may include but not be limited to, GCP vendor audits, clinical study specific audits (e.g. investigator site, TMF), and internal process audits
  • Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
  • Contribute to business development efforts, including the authoring of proposals for new client engagements and identifying business development opportunities in existing clients and educating clients on Halloran services

 

Qualifications:

Required:

  • Bachelor’s Degree and a minimum of eight years of related experience, including five years of Sponsor experience
  • Deep expertise in GCP
  • Demonstrate good judgment in selecting methods and techniques for obtaining solutions

Preferred:

  • Certification or advanced training
  • Early stage clinical trial experience

 

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 opportunities for all applicants and employees.  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.

 

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

 

No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by a member of Halloran’s Human Resources or Talent Acquisition teams.

Halloran Consulting Group | Consultant, GCP Quality