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Head of Clinical QA & Compliance Programs

Reference Number: 2854
Location: MA

Our client is an international biopharmaceutical company.  They have asked us to assist them in their search for a Head of Clinical QA & Compliance Programs.

Under the direction of the Head of R&D Clinical and Medical QA and Compliance, this position is responsible for providing the strategic direction and GCP compliance & Auditing leadership to the programs being managed by the Clinical Development organization.  Primary responsibilities for this role are to develop and successfully implement auditing, inspection and compliance strategies for specific development programs and activities governed by Good Clinical Practices (GCPs) and applicable regulations.  Primary duties include but are not limited to liaising with various internal R&D functions and external groups including Contract Research Organizations (CROs), regulatory bodies and investigator sites ensuring a high level of quality and consistency across the programs and studies, development of the master audit plan as a means to ensure compliance with appropriate policies and procedures, contributions to due diligence activities as appropriate, serving in an advisory/consultative role in compliance related manners, assisting program teams in implementing corrective and preventive actions, enabling program team to be inspection ready, and supporting a culture of sustainable compliance.

Major tasks and responsibilities will include:

  • Leads the development and execution of the audit activities associated with GCPs and applicable regulatory requirements.
  • Collaboratively works with key stakeholders from R&D and other Program Compliance colleagues to ensure a robust audit strategy.
  • Ensures the appropriate corrective and preventive actions are completed in a timely manner.
  • Identifies 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 matters and supports Program team in implementing corrective and preventive actions.
  • Supports Program 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.
  • Participates in Due Diligence activities as appropriate.
  • Develops an overarching strategy related to proactive and sustainable compliance for the assigned programs.
  • Leads a team consistent with company expectations.
  • Ensures every employee knows what is expected of them, what it takes to be successful, and how they are progressing.  Holds everyone accountable to achieve results while demonstrating company values.
  • Helps employees continually grow through challenging opportunities so they can realize their potential.
  • Serves as a member of the R&D Clinical and Medical QA & C Leadership Team to influence the operations and future strategy of the R&D Clinical and Medical QA & Compliance function.
  • 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 preferred.
  • At least 10 years of pharmaceutical experience.
  • Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP auditing, and at least 7 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 2854. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.