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Head of Quality/ Senior Director

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Boston, MA
$175,000 - $225,000
Job Type
Direct Hire
Aug 23, 2016
Job ID

As Head of Quality, this position will be responsible for driving a comprehensive quality strategy and quality system for the company. Working with the company senior leadership and line function heads to define an overarching quality strategy, systems and culture that is applicable to the activities that occur within the company.  That will allow the basis to structure/build the group necessary to execute on the agreed upon strategy.

Activities include management and GMP oversight of product, testing, stability, validation data, documentation, and records relating to the manufacturing, sampling, testing, analysis, and investigation of clinical and commercial drug materials manufactured by or for the company.  Activities also include management and GCP, GLP and PV oversight of safety, clinical and nonclinical quality aspects of the companies programs.

Functions and Duties:

  • Manage the Quality Organization.  Develop, implement, and administer the Quality Management System.  Continue to implement and enhance the required Quality Systems.
  • Develop, direct, and/or oversee QA and QC activities and programs for internal and third party supplier operations that are subject to GXP regulations and guidelines; establish QA Agreements, as needed.
  • Provide direct QA oversight of contract organizations. 
  • Provide expert technical analysis and evaluation of QA issues affecting corporate projects, establish risk mitigation and best practice strategy for resolution.
  • Direct all Corrective Action/Preventative Action (CAPA) investigations (CMC, clinical, nonclinical), investigate suspicions of Fraud and or Misconduct, and Serious Breach reporting where required.
  • Oversee and/or Facilitate audit requests including due diligence visits.
  • Lead inspections by Regulatory Authorities.  Support preparation of clinical trial sites, contract manufacturers, and nonclinical testing laboratories for audits (e.g., Pre-Approval Inspections) by Regulatory Authorities.
  • Provide training (GMP, GCP, GLP) to company

Preferred Qualifications:

  • B.S. scientific degree preferred.  Other degreed candidates with Quality experience will be considered
  • 15 plus years in the Pharmaceutical Industry, with at least five years in a Quality leadership role.  Experience in Clinical, QC, Manufacturing and/or Regulatory also a plus in addition to Quality.