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Associate Director, R&D Compliance and Process

Reference Number: 3116
Location: MA

Our client is an international biopharmaceutical company.  They have asked us to assist them in their search for an Associate Director, R&D Compliance and Process.

Major tasks and responsibilities will include:

  • Executes registries and late phase audit plans.
  • Leads the execution of the audit activities associated to GPP and appropriate GCP standards and applicable regulatory requirements.
  • Works collaboratively with key stakeholders from project teams to other QA & Compliance colleagues to ensure audit plan execution.
  • Ensures the appropriate corrective and preventive actions are completed in a timely manner.
  • Reviews metrics and trends to identify potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.
  • Escalates issues of critical noncompliance and/or lack of urgency in remediation to management.
  • Audit includes but is not limited to investigator sites, CROs, and other vendors.
  • Serves in an advisory/consultative role in compliance related manners and supports project teams in implementing corrective and preventive actions.
  • Supports project team to be inspection ready with a culture of sustainable compliance in coordination with the Process Compliance and Compliance Operations groups.
  • Works with the R&D QA & Compliance Quality Operations function to perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management.
  • Executes the overarching strategy related to proactive and sustainable compliance for the assigned projects.
  • Collaborates and coordinates with Global Compliance in areas related to publications support from registries, grants reviews and evaluation of applicable meeting approvals.
  • Leads contract auditors to provide auditing services to sites, clinical CROs and applicable vendors.
  • Ensures consultants have appropriate subject matter expertise and knowledge to conduct audits and oversees the timely development and distribution of audit reports and follow up actions.
  • Manages the auditor’s budget for the conduct of the audit and gets appropriate approvals from management.
  • Develops and manages the strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections, inspections and investigator site audit inspections for assigned programs.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a life science required.
  • Master’s degree in management or scientific discipline is a plus.
  • At least 7 years of pharmaceutical experience.
  • Experience in product development, clinical operations, regulatory compliance, GCP auditing.
  • At least 3 years of direct management experience.

 

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 3116. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.