Quality Assurance

  • location: Lexington, MA
  • type: Contract
  • salary: $57.17 - $67.26 per hour

job description

Quality Assurance

Clinical Compliance Specialist

Job Summary

Clinical Compliance Specialist Primary Role: Under the direction of the Head of R&D Clinical and Medical Program Compliance, this position is responsible for leading the QA and Compliance activities of assigned programs being managed by the Clinical Development organization.

Job Responsibilities

  • Primary responsibilities for this role are to provide professional expertise and strong leadership in Good Clinical practice (GCP) and applicable regulations and guidances and to proactively identify compliance status and issues/risks in assigned clinical studies within the organization.
  • Primary duties include but are not limited to liaises 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, contribute to the master audit plan and assists project teams in implementing corrective and preventive actions, enable project team to be inspection ready and support a culture of sustainable compliance.
  • Execution of Program Audit Plan Leads the execution of the audit activities associated to GCPs and applicable regulatory requirements.
  • Collaboratively works with key stakeholders from project teams 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.
  • Audit includes but is not limited to investigator sites, central IRBs, CROs,. Compliance Support 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.
  • 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 programs.
  • Management 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 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.
  • Regulatory Agency Support 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.
Education & Qualifications

  • Bachelors degree in a life science required; Masters Degree in management or scientific discipline a plus.
  • At least 4 - 6 years of pharmaceutical experience.
  • Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP auditing and at least 2 years of management experience.
  • Travel required to sites where clinical and pharmavogilance colleagues operate.
  • Must have a global mindset.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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