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Director of Quality Assurance

Ref #: 330
Location: Boston Area
Salary: 200,000 Per Annum
Sector: Quality
Type: Fixed

I’m looking for a quality leader who enjoys people mentorship to lead Quality Assurance with a.  focus on commercial and clinical manufacturing at small (<300 person) oncology company.

The company has a strong pipeline including a late-phase product that could be a game changer for people with NSCLC.

This person will design, plan, implement, and direct the QA function and a QMS which supports clinical development and regulatory approval of products. This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs.

What you’ll do:

  • Own the Quality Manual and Quality Policies/Procedures
  • Formulate and administer SOPs
  • Own final batch record review and disposition
  • Own Deviation Management and Change Control
  • Quality oversight of IT systems used to support Quality
  • Facilitate review of CMC sections for Regulatory submissions
  • Define, develop and implement short- and long-term strategies and goals
  • Implement a continuous improvement plan
  • Represent QA in internal and external inspections and audits

What I’m looking for:

  • Proven ability to effectively develop, communicate and gain support for execution plans and strategies with a wide range of stakeholders
  • Leadership and management skills to manage a high performing team
  • Experience working with vendors and contractors
  • Experience with regulatory submissions and commercial distribution
  • Minimum of 10 year of industry experience, ideally with 8 years of experience leading a quality function

There may be up to 50% travel, including international travel. Position can be based either in Southern California or in Boston, MA.

If this sounds of interest to you, please apply today!