Senior Manager/Associate Director, Quality Systems

Lexington Permanent USD140,000 - USD180,000
  • Join a growing clinical stage biotech start-up, owning and overseeing the QMS
  • Work on cutting edge cancer technology fast-tracked by the FDA

About Our Client

Our client is an exciting clinical stage biotech start up focused on treatments for Cancer patients.

Job Description

  • Provide Expertise on implementation and maintenance of the Quality Management System (QMS), both electronic and paper based.
  • Develop, implement and manage an integrated viewpoint for the Quality System.
  • Develop Quality System (GXP) including GDP procedures and administer documents for both clinical and commercial operations.
  • Create, implement and manage key performance and Quality indicators and metrics/dashboards.
  • Manage the inspection process for regulatory and partner audits and responses to audits.
  • Ensure and manage the vendor qualification process.
  • Partner with functional teams to identify, administer and implement optimized system designs for document management, change control, specifications, deviations and CAPAs and training.
  • Manage Internal audit program and process improvements for Quality Systems.
  • Develop/enhance and manage training program, including annual GMP 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 or Advanced degree in science or equivalent experience
  • Relevant Quality experience
  • Min. 10 years direct experience in the Pharmaceutical, Biotechnology or related industry
  • Extensive knowledge and understanding of global requirements for cGXP and quality systems for clinical and commercial manufacturing and supply
  • Ability to interpret external regulatory/compliance documents and internal metrics to propose appropriate mitigation
  • Working knowledge of software solutions for QMS
  • Excellent leadership skills and a history of developing subordinate quality professionals
  • Small molecule experience preferred

What's on Offer

  • Very competitive base salary and compensation package
  • Opporunity for career growth and development
  • Join one of 2020 Best Places to Work in Massachusetts
Moriah Sweeney
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Job summary

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