Director, Clinical Quality Assurance

Full Time in Quality Assurance/ Quality Control
  • Boston, Massachusetts, United States View on Map
  • Apply Before : 5th August 2024
  • Salary: $200,000 - $230,000 / Annually

Job Detail

  • Remote Work Possible

Job Description

Director, Clinical Quality Assurance

Location: New Jersey

Albion Rye Associates are partnered with a US Biotech with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance.

Leading a small team, you will be part of the Quality Assurance management function, acting as the Lead GCP Auditor, reviewer and mentor for the team .

This is an excellent opportunity to develop skills within a fast-paced Biotech, with a rich pipeline of studies across Phase I – III.

Responsibilities (including, but not limited to):

  • Develop and implement QA compliance programs as assigned
  • Conduct investigator site, service provider and internal audits as needed
  • Develop, review, and revise SOPs for GCP/GLP/GVP QA processes
  • Promote compliance within the company and represent QA
  • Build, develop, and maintain good working relationships with internal and external partners
  • Matrix manage projects, including cross-functional teams
  • Provide compliance advice as requested or needed
  • Help lead in inspections, in agreement with QA management
  • Participate in company preparations for regulatory inspections
  • Review and identify improvements that enhance the quality assurance system
  • Assist Quality management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement
  • Establish and maintain quality metrics and reporting
  • Coordinate, develop, maintain and/or provide training as requested
  • Keep up with GCP/GLP/GPV requirements and developments


  • Requires a bachelor’s degree (BS/BA/ BScN or higher); masters-level degree is preferred, with a minimum of three (3) years managerial Biotechnology/pharmaceutical experience and a minimum of eight (8) years biotechnology/pharmaceutical industry experience
  • Advanced knowledge of the pharmaceutical drug development process and current knowledge of FDA regulations for clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is a plus
  • Solid well-grounded experience in GXP compliance including knowledge and experience in preparation of Clinical sections of INDs, CTAs, BLAs, MAAs and NDSs submissions
  • Proficient in use of electronic clinical database software and other programs such as Microsoft Office

Please email Megan Siggins for more information.


Albion Rye Associates are one of the worlds leading staffing agencies supporting professionals within; Biotech, Pharmaceuticals, Medical Device, Medical & Healthcare Communications, Public Relations, Healthcare Advertising, Market Access, Health Economics and Market Research.

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