Quality Recruiting. Established Experts.

Director/Senior Director, GCP Quality Assurance

Reference Number: 3720
Location: MA

Our client is global biopharmaceutical company. They have asked us to assist them in their search for a Director/Senior Director, GCP Quality Assurance.

Major tasks and responsibilities will include:

  • Leads development, implementation, and maintenance of GCP Quality Systems and SOPs.
  • Manages cross functional relationships with internal and external stakeholders and is the Quality Assurance representative to clinical teams.
  • Provides QA oversight and auditing of eTMFs.
  • Leads preparation for Clinical Operations (corporate and third-party) inspection-readiness.
  • Serves as an SME for areas of responsibility during regulatory inspections, and directly manages inspection Ready -Room activities.
  • Designs and implements a risk-based clinical Quality Assurance management system in partnership with the Clinical Operations, Regulatory, and Pharmacovigilance teams.
  • Identifies QA and compliance related issues and implements solutions to ensure timelines are maintained.
  • Establishes metrics and reports the state of GCP Quality and compliance of clinical trials to senior management.
  • Ensures Clinical Operations activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards.
  • Reviews key safety, clinical, and regulatory documents, such as DSUR, IB, IND and NDA.

We seek candidates with the following qualifications:

  • Requires a minimum of a Bachelor's Degree in Nursing.
  • A PhD or MS in a clinical/medical science highly preferred.
  • Relevant professional certifications are a plus.
  • Must have 10+ years of relevant pharmaceutical industry experience.
  • Direct experience in managing Health Authority GCP Inspections required. Experience leading/hosting BIMO inspections preferred.
  • Must have experience leading document review (Source data verification) initiatives.
  • Requires excellent knowledge of Global GCP regulations and industry standards.
  • Must have knowledge of the infrastructure and operational characteristics of CROs and centralized services.
  • Must be willing to travel domestically and internationally up to 25%.

If interested, please email your resume as a Word attachment to us, reference 3720.  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.