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Director Quality Assurance (Remote)

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: US$160000 - US$220000 per year
  • Job reference: 318181/001_1558476816
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 21/05/2019

Director Quality Assurance (Remote)

US HQ - Maryland

We have partner with a clinical stage oncology focused Biopharmaceutical company in Maryland that is rapidly expanding in the US in its search for a Director Quality Assurance. This company just completed its series C round of funding bringing its total investment to nearly $250 million. With a strong pipeline of large and small molecules this company is set to explode in growth in the coming years. If you are looking to get in with a stable start-up company with pre-IPO equity then don't hesitate to apply!

Responsibilities:

  • Lead and provide overall quality assurance strategies for company's clinical development.

  • Define and execute overall quality assurance activities in collaboration with Clinical Operation, pharmacovigilance and CMC.

  • Perform risk assessments to identify audit targets, conduct internal and vendor audits, develop and maintain audit tools, checklists and plans, and author or review audit reports and other audit-related documentation.

  • Ensures timely communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management. Define and implement the health authority inspection strategies in support of the submissions and GCP compliance.

Ideal Candidates Will Have:

  • BS in Sciences required; advanced degree highly preferred

  • 8+ years of pharmaceutical or biotech industry experience

  • 5+ years of hands-on quality assurance lead experience with at least 3 years of GCP auditing

Compensation:

competitive base + target bonus + Pre - IPO stock + exceptional health care + FULLY REMOTE flexibility for non-local candidates.

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