Quality Assurance Specialist

4 days ago

London, Greater London, United Kingdom Pulse Infoframe Full time

Pulse Infoframe is a leading global health technology company focused on cancer and rare/orphan diseases. Our mission is to advance medical knowledge by sharing data across boundaries, making us leaders in Real World Data/Evidence. Our customers include top pharmaceutical and biotechnology companies, academic medical centers, and patient advocacy organizations.

We are seeking a Quality Assurance Specialist to join our Quality and Scientific team responsible for maintaining our cloud-based platform that powers our products. Reporting to the Chief Financial Officer and Chief Executive Officer, this role ensures the day-to-day management of the Quality Management System (QMS) and electronic trial master file system (eTMF), including review and approval of QMS and eTMF documents, and generating reports to measure completeness, accuracy, and timeliness of the eTMF and QMS.

This position requires adherence to Good Clinical Practice (ICH-GCP) guidelines, other regulatory requirements, and standard operating procedures (SOPs). The successful candidate will maintain all company Quality documents to current revisions, including eTMF, SOPs, and Policies. They will also ensure all Quality documents are current and have been trained by all respective employees and contractors/consultants.

Responsibilities include:

  • Managing the Quality Management System (QMS) and electronic trial master file system (eTMF)
  • Oversight of the review and approval of QMS and eTMF documents
  • Generating reports to measure completeness, accuracy, and timeliness of the eTMF and QMS
  • Maintaining all company Quality documents to current revisions
  • Ensuring all Quality documents are current and have been trained by all respective employees and contractors/consultants

Requirements include:

  • Bachelor's degree in a related field
  • 3-5 years of experience in a quality control setting (healthcare and real-world evidence experience preferred)
  • Experience with clinical trials and regulatory documents is preferred
  • American Society of Quality (ASQ) certification preferred
  • Methodical and compliant approach with flexibility when needed

The ideal candidate will have high ability to manage priorities and local study team expectations, display excellent organization and time management skills, and ability to multi-task in a high-volume environment with shifting priorities. This is a remote, hybrid or on-site dependent on candidate location job type with a salary range of $80,000 - $110,000 per year.

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