Head, Experimental Medicine Quality (Oncology)

Collegeville, Pennsylvania; Waltham, Massachusetts
February 11 2021
Organization Type
The Oncology Experimental Medicine Unit (EMU) is seeking a Head, Experimental Medicine Quality. The EMU is responsible for Oncology's biomarker and diagnostics activities and requires a Head of Quality with expertise in regulated clinical laboratory activities and diagnostic development. Responsibilities will include establishing and managing a team of Quality professionals and oversight of the EMU Quality program. The successful candidate will work within the EMU and across departments to ensure clinical trial predictive diagnostic and other experimental medicine biomarker specimen acquisition, testing, results reporting, and archiving are compliant with all applicable regulations.

This position will be responsible for ensuring compliance across Oncology companion and complementary diagnostic projects. While the EMU is building robust processes to enable Quality upon initial project execution, a Quality function itself is required to ensure output matches expectations.

Key responsibilities
  • Build and manage a team of Quality personnel
  • Manage EMU laboratory and related facility assessments
  • Develop and monitor Quality metrics for EMU activities including clinical trial specimen management and clinical testing
  • Manage the development of EMU SOPs, GUIs, other controlled documents in harmonization with GSK's Quality System
  • Manage overall EMU Quality including specimen operations, clinical biomarker and diagnostic testing, sample bank
  • Department training
  • Identify, document, and model risks; with matrix team contribute to risk mitigation efforts
  • Represent the Experimental Medicine Unit in cross organization Quality workstreams
  • Maintain Quality aspects of service provider agreements
  • Audit readiness at all times
  • Other duties as assigned

  • Position requires analytical skills, critical thinking, communication skills
  • Direct experience working in a regulated diagnostics and /or clinical testing setting
  • The Head of EMU Quality will need to be familiar with local regulations from across the globe to ensure testing compliance.

Certification / training with any of the following:

GCP Certification

CAP/CLIA Certified

ISO 15189 Certification

21 CFR 820 Certification

21 CFR 11 Training

ISO 13485 Certification

CAP BAP Accreditation

HTA Submissions

GDPR Compliance

GCLP Training

Clinical Trials Directive / Clinical Trials Regulation

Regulations of Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA), National Medicinal Products Administration (NMPA)

Preferred Qualifications
  • Stem Nursing highly desirable
  • Clinical Trials Directive / Clinical Trials Regulation

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