Sr. Manager/Associate Director, Quality Systems

Cambridge Permanent USD150,000 - USD180,000
  • Join a clinical-stage company focused on viral immunotherapies
  • Opportunity to build out the Quality infrastructure

About Our Client

A clinical-stage biotech company focused on the development of viral immunotherapies for cancer patients.

Job Description

  • Oversight of Quality Systems and Validation Programs
  • Developing a system for the issuance, review & approval of manufacturing batch records.
  • Maintenance and metrics reporting of Quality Systems.
  • Quality oversight of computer systems, facility, utilities, and equipment commissioning and qualification activities at the Andover manufacturing facility.
  • Supporting cleaning and environmental monitoring qualification.
  • Supporting review and approval of investigations related to protocol discrepancies, equipment/instrument failures, ensuring resolution & risks mitigated, impacts to equipment, product and processes are adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions implemented.
  • Supporting implementing and maintenance of Preventative Maintenance/ Calibration Program.

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

  • B.S. degree in scientific discipline or closely related field is required.
  • At least 10+ years of post-degree Quality experience in the biotechnology/pharmaceutical industry.
  • Extensive knowledge of GxP and QA principles, practices, and standards
  • Strong knowledge of global regulations (EU, US)
  • Direct experience in the commissioning, qualification and validation of facilities, utilities, production, laboratory, and support equipment required.
  • Experience with Quality Risk Management and Change Controls

What's on Offer

  • Offers a comprehensive benefits package including health, dental, life insurance, 401k, unlimited vacation and much more.
  • Salary: commensurate with role and experience
Meghan Landry
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Meghan Landry
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