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Head of Research Compliance

Reference Number: 2928
Location: MA

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

Under the direction of the Head of R&D QA and Compliance, the Head of Research Compliance is responsible for providing the strategic direction and leadership of the Research Compliance function within R&D QA & Compliance.  Primary responsibilities for this role are to develop and successfully implement auditing, inspection and compliance strategies for research and development activities governed by Good Laboratory Practices (GLPs) and other applicable regulatory requirements.  Primary duties include but are not limited to liaising with various internal R&D functions and external groups including Contract Research Organizations (CROs), laboratories, non-clinical research units, regulatory bodies and an ensuring a high level of quality and consistency across the R&D programs, execution of the master audit plan as a means to ensure compliance with appropriate policies and procedures, participation in due diligence activities as appropriate, serve in an advisory/consultative role in compliance related manners, assists R&D in implementing corrective and preventive actions, enable R&D to be inspection ready and support a culture of compliance.

Major tasks and responsibilities will include:

  • Leads the development and execution of the audit activities associated to GLPs and other applicable regulations for the management of research laboratory functions.
  • Collaboratively works with key stakeholders from R&D to ensure a robust audit strategy.
  • As appropriate escalates issues of critical non-compliance and/or lack of urgency in remediation to senior management.
  • Audits include but are not limited to GLPs CROs and can be for cause or routine.
  • Serves in an advisory/consultative role in compliance related manners and supports R&D in implementing corrective and preventive actions.
  • Supports R&D to be inspection ready with a culture of sustainable compliance.
  • Works with the R&D QA & Compliance Quality Operations function to perform root cause analysis of compliance issues and develop appropriate metrics for tracking, trending and reporting to functional and senior management.
  • Participates in Due Diligence activities as appropriate.
  • Develops an overarching strategy related to proactive and sustainable compliance.
  • Serves as a member of the R&D QA & C Sr. Leadership Team to influence the operations and future strategy of the R&D QA & Compliance function.
  • Develops and manages the strategies for the preparation, hosting and responses to regulatory agency inspections related to GLPs and other regulatory requirements associated with accreditation, etc.

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.
  • Ideally will have broad experience in product development, clinical operations, regulatory compliance, Laboratory and non-clinical operations including GLP auditing and at least 7 years of direct management experience.
  • Domestic and international travel required. Must travel globally to sites where clinical and pharmacovigilance colleagues operate. Must have a global mindset.

 

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 2928. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.