Senior Director of Quality Assurance

3 weeks ago


Brockton, Massachusetts, United States BioSpace, Inc. Full time
Job Overview

This is a critical role that will lead the quality assurance function for a pipeline product in clinical phase studies. The ideal candidate will have extensive experience in directing quality-related activities, process development, and compliance with regulatory requirements.

Responsibilities
  1. Establish and maintain a risk-based and scientific quality system and decision-making process.
  2. Audit manufacturing facilities, vendors, customers, and outside contract organizations.
  3. Ensure phase-appropriate GMP operations are in compliance and maintain an efficient workflow.
  4. Provide leadership and management within the department, including performance appraisal and individual development.
  5. Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies.
  6. Act as the company's representative during regulatory agency and customer inspections.
Qualifications
  1. Minimum 10 years of experience in quality assurance, with a strong background in GMPs, GLPs, and GCPs.
  2. Experience with Phase I through IV, particularly Phase III, and regulatory approval processes.
  3. Ability to manage staff and projects, and variable workloads.


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