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Associate Director, Clinical Quality Assurance

Reference Number: 3714
Location: CA

Our client is global biopharmaceutical company. They have asked us to assist them in their search for an Associate Director, Clinical Quality Assurance.

Major tasks and responsibilities will include:

  • Plans and coordinates continuous improvement of quality processes and systems that assure compliance of clinical study-related activities.
  • Provides effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members.
  • Identifies, evaluates, and communicates risks to critical trial processes and data with recommendations for resolution.
  • Improves, maintains, and implements GCP quality systems.
  • Oversees external and internal audit plans and activities.
  • Trains company staff and external partners in GCP compliance and the company’s clinical practices and procedures.
  • Plans and oversees effective audits of investigator sites, documents, Trial Master Files, vendors, and internal processes.
  • Provides compliance guidance and oversight of trial-related duties and functions.
  • Support GCP inspection readiness.

We seek candidates with the following qualifications:

  • Requires a Bachelor’s degree. An advanced degree in a scientific field highly preferred.
  • Must have 5+ years of experience in Clinical Quality Assurance.
  • Must have broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R2) for Good Clinical Practice and experience with all phases of clinical trials.
  • Must have knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21CFR Part 11 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
  • Requires experience supporting inspection-readiness activities resulting in successful agency (FDA, EMA) inspections
  • Must be able to travel both domestic and internationally up to 10%.

If interested, please email your resume as a Word attachment to us, reference 3714.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.