Associate Director/Director, Quality Assurance

Providence Permanent USD160,000 - USD200,000
  • Join exciting biotech company preparing for an upcoming BLA filing
  • Work on innovative biological drug device combination technology

About Our Client

Our client is an exciting clinical stage biotech start up focused on the treatment of retinal disesases and expecting to file their BLA within the next year.

Job Description

  • Lead Quality Assurance team member direct reports, inclusive of Associates, Specialists, and Managers
  • Coaches / mentors staff as a means to ensure performance towards goals and provide professional development
  • Serve as a member of the Quality Leadership and / or Quality Management Teams and advise management on Quality practices, issues of concern and resolution strategies and tactics with partners
  • Cross functional partner with management and associates in Manufacturing, Quality, Operations and Development
  • Providing advice and expertise to employees and colleagues to ensure the development, management, and implementation of Quality policies
  • Lead Quality Operations and Quality Management System processes (Lot Disposition, Deviation, Change Control, CAPA, OOS, Complaints, etc.).
  • Deliver training activities sharing expertise in GMP operations and compliance
  • Developing strategies to ensure best practices and processes are incorporated into procedures and specified required training

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelor's Degree or higher in Science or Engineering or equivalent combination of education and experience (BS degree w/ minimum of 15 years; MS degree w/ minimum of 10 years, PhD w/ minimum of 7 years)
  • Minimum of 10 years of Quality Assurance work experience within the cGMP biopharmaceuticals industry
  • Previous managerial and leadership experience in Quality Assurance commensurate with position responsibilities and requirements
  • Biologic QA Operations or QA Systems or External QA/Compliance experience is a plus
  • Phase III Clinical Development to Commercial QA experience is a plus

What's on Offer

  • Competitive base salary and benefits
  • Opportunity for Career Growth and Progression
  • Opportunity to grow with a fast-growing start up working on innovative, cutting-edge technology
  • Work in one of New England's Biotech Hubs
  • Mentorship responsibilities and ability to grow out and own Quality function
Moriah Sweeney
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Moriah Sweeney
Job Reference