Principal Consultant, GxP Quality

Boston

 

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 Principal Consultant to join its Quality practice area. As a Principal Consultant, Quality, you will provide leadership, strategic vision and support to the development quality consulting business to ensure successful engagement, scoping, execution and delivery of client work. Additional responsibilities include providing 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:
  • 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
  • Develop novel methodologies in their area of expertise
  • Establish timelines, quality objectives and   resource objectives for a project
  • Defines methodology for practice area within their area of expertise
  • Lead and manage quality team members to ensure client, employee, and company goals are achieved, either in a matrixed or direct management relationship
  • Provide leadership, oversight, and/or delivery of the following quality consulting services:
  • Serves as the client Engagement Lead for key Halloran clients
  • Publish and speak at industry meetings and participate in professional consortia, working groups, etc. in one or more practice area
  • 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 sixteen years of both tactical and strategic experience in pharmaceuticals/biopharmaceuticals/biotech and/or related industries with a concentration in one of more of the following functions: Quality, Quality Systems, Regulatory Compliance & Intelligence, Clinical Development, Operational Excellence, Inspection Preparation, Root Cause Analysis and Risk Assessment
  • In depth knowledge of global GxP regulations and standards and good regulatory compliance practices, policies, and  procedures
  • A strong customer focus and ability to prioritize and adapt to business needs are required
  • Demonstrated project management skills; experience leading and participating on cross-functional teams
  • Experience communicating/presenting to various levels of senior management and external agencies/partners
  • Extensive knowledge of investigation techniques and tools
  • Extensive knowledge of risk assessment strategies and tools

Preferred:

  • Previous experience with small and growing biotechnology and pharmaceutical companies
  • Post-graduate coursework

 

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.

Halloran Consulting Group | Principal Consultant, GxP Quality