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Senior Manager/Associate Director, GCP Quality Assurance

Reference Number: 4038
Location: MA

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

Major tasks and responsibilities will include:

  • Participates in the development, implementation, and maintenance of GCP Quality Systems and SOPs.
  • Manages the development of risk-based auditing schedules.
  • Oversees the conduct of the GCP vendor procedures.
  • Serves as the expert on global GCP regulations and guidances.
  • Provides QA oversight and auditing of Trial Master Files.
  • Provides assistance and/or oversight of consultant mediated audits.
  • Develops, recommends, and conducts follow-up on corrective actions.
  • Plans and conducts complex audits / mock inspections in agreement with QA management.
  • Assists with the preparations for GCP inspection-readiness.
  • Assists with the management of GCP Inspections and inspection Ready-Room activities
  • Continues to develop as an SME for areas of responsibility during regulatory inspections.
  • Collaborates with the Clinical Operations, Drug Safety & Pharmacovigilance, and Regulatory teams.
  • Contributes to the design and implementation of a risk-based clinical Quality Assurance management system.
  • Identifies QA and compliance related issues and implement solutions to ensure timelines are maintained.
  • Assists with the establishment of metrics.
  • Assists with reporting of the state of GCP Quality and compliance of clinical trials to leadership and stakeholders.
  • Ensures Clinical Development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines, as well as industry standards.
  • Reviews key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA.
  • Provides consultation in the interpretation of regulations and guidelines as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study.
  • Stays abreast of industry developments, such as forthcoming regulations, guidance, best practices, etc.

We seek candidates with the following qualifications:

  • Master’s degree in a clinical/medical science required, PhD highly preferred.
  • Must have a minimum of 6+ years of relevant pharmaceutical or biotech industry experience.
  • Requires experience supporting Regulatory Authority GCP Inspections.
  • Experience supporting BIMO inspections is highly preferred.
  • Must have experience in all relevant areas, such as quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, GxP auditing, etc.
  • Requires experience leading document review (Source data verification) initiatives and deploying both internal and external resources, in a tight timeline to meet business objectives.
  • Must have excellent communication, writing and presentation skills for effectively interfacing with internal and external organizations, collaborators and customers.
  • Requires ability to assess complex issues, break down into components and propose viable solutions.
  • Must have the ability to foster effective relationships with vendors, investigators and colleagues.
  • Advanced knowledge and understanding of Global GCP regulations and industry standards required.
  • Requires proficiency in study monitoring activities.
  • Must be able and willing to travel domestically and internationally up to 10%.

If interested, please email your resume as a Word attachment to us, reference 4038.  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.