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Senior Manager, Quality Oversight of Clinical Programs

Reference Number: 3182
Location: MA

Our client is a global biopharmaceutical company.  They have asked us to assist them in their search for a Senior Manager, Quality Oversight of Clinical Programs.

Major tasks and responsibilities will include:

  • Serves as a CQA Compound Lead for assigned clinical programs providing GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and/or improve the quality of the company’s research to ensure the protection of subjects’ safety, rights, and well-being as well as the integrity and credibility of data generated.
  • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).
  • Fosters the company’s Core Values when collaborating with cross functional teams to advance quality activities while remaining independent and autonomous.
  • Develops strategic audit plans assigned programs, ensures audits are conducted in accordance with the plan, evaluates CAPA plans and drives CAPAs to closure in accordance with company standards and policies.
  • Manages and leads domestic and international audits for Clinical Investigators, Trial Master Files (TMF) and/or GCP document audits to ensure compliance to ICH GCP, applicable regulations, and company standards.
  • Participates as a co-auditor for investigations into scientific misconduct and/or serious breach of GCP, analyzes investigational findings to identify root cause.
  • Assures reporting of potential or confirmed violations, as appropriate, in accordance with company standards.
  • Assigns, reviews and approves audit reports for content, format, regulatory risks, and compliance with applicable standards.
  • Identifies and escalates critical quality issues appropriately to CQA Associate Director for Quality Oversight of Clinical Programs.
  • Contributes to the development and implementation of continuous quality improvement initiatives.
  • Provides inspection support as necessary for Regulatory Agency inspections held at the company’s facilities or Clinical Investigator sites.

We seek candidates with the following qualifications:

  • Advanced degree is strongly preferred.
  • 9 years of relevant GCP QA work experience, or relevant comparable background and 5 years of relevant GCP QA experience.
  • Up to date on FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments and ICH GCP guidelines.
  • Experience with clinical trials involving drugs, biologics, devices and drug/ device combinations.
  • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
  • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
  • Possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects.
  • Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
  • This position may require up to 30% travel.

 

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 3182. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.