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Director Clinical Quality & Compliance

Reference Number: 3262
Location: MD

Our client is a global pharmaceutical company.  They have asked us to assist them in their search for a Director, Clinical Quality & Compliance.

Major tasks and responsibilities will include:

  • Assigns, maintains and manages the activities of Clinical Quality Assurance personnel and ensures high performance, and continuous development.
  • Collaborates with other CQC senior staff to manage workload assignments and ensure that CQC responsibilities are carried out effectively.
  • Provides expert clinical GCP input into new and current business processes, improvement projects and operational interactions.
  • Assists in supporting teams with internal and regulatory audits and inspections. This also includes facilitation of inspection readiness, inspection management preparations, and audit response support.
  • Develops, implements, and manages assessments and reviews and other oversight activities (such as monitoring quality and compliance metrics) to ensure compliance with standards of quality.
  • Establishes audit and GCP training and best practices for all clinical cross functional groups; reviews and scrutinizes learning curriculum assignments to ensure appropriate and reasonable curricula are in place.
  • Supports vendor oversight processes and serves on any assigned operational and/or governance committees. This includes establishing, maintaining, and documenting appropriate processes for vendor SOP reviews.
  • Establishes and maintains relevant CRO Vendor master lists of relevant SOPs and processes for mutual updating of documents.
  • Develops, implements and manages the Quality and Compliance Issue reporting process.
  • Acts as an expert advisor/consultant to operational teams on matters of compliance and quality issue management, ensuring consistent quality standards and fostering strong working relationships.

We seek candidates with the following qualifications:

  • Must have a Bachelor’s degree in a biologic, nursing or related scientific discipline.
  • An advanced degree in a scientific or business discipline is preferred.
  • Must have knowledge and experience of drug development and the execution of clinical trials.
  • Must have a thorough understanding of the challenges relating to global clinical trials; and the importance of compliance.
  • An understanding of ICH GCP and experience with global regulations and guidelines; knowledge of FDA and EU regulations is required.
  • Must have experience in Quality Issue and CAPA management.
  • Experience in conducting various GCP compliance audits/assessments/document reviews is required.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3262. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.