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Program Compliance Leader

Reference Number: 2856
Location: MA

Our client is an international biopharmaceutical company.  They have asked us to assist them in their search for a Program Compliance Leader.

Under the direction of the Head of R&D Clinical and Medical Registry and Late Phase QA and Compliance, this position is responsible for leading the QA and Compliance activities of assigned programs being managed by the Clinical Development organization.  Primary responsibilities for this role are to provide professional expertise and strong leadership in Good Clinical practice (GCP), Good Pharmacoepidemiologic Practices (GPP) and applicable regulations and to proactively identify compliance status and issues/risks in assigned clinical studies or a program within the organization.  Primary duties include but are not limited to liaising with various internal R&D functions and external groups including Contract Research Organizations (CROs), contract auditors and investigator sites ensuring a high level of quality and consistency across the studies, contributing to the master audit plan and assisting project teams in implementing corrective and preventive actions, enabling project team to be inspection ready, and supporting a culture of sustainable compliance.

Major tasks and responsibilities will include:

  • Leads the execution of the audit activities associated to GPP and appropriate GCPs and applicable regulatory requirements.
  • Collaboratively works with key stakeholders from project teams and other Program Compliance colleagues to ensure audit plan execution.
  • Ensures the appropriate corrective and preventive actions are completed in a timely manner.
  • Assists in the review and Identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.
  • As appropriate, escalates issues of critical non-compliance and/or lack of urgency in remediation to senior management.
  • Serves in an advisory/consultative role in compliance related manners and supports project team 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.
  • Performs program specific root cause analysis of compliance issues and provides 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 and evaluation of applicable meeting approvals.
  • Leads a team of 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 oversee the timely development and distribution of audit reports and follow up actions.
  • Manages the auditor’s budget for the conduct of the audit.
  • 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.

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.

 

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 2856. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.