Asset Quality Lead, GCP Inspections; Director, Oncology

Overview

Job Summary: The Asset Quality Lead, GCP Inspections (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols. The AQL brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the AQL will ensure program and study level quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS.

The AQL is the point person to the cross functional study team and other relevant stakeholders for quality risk management, quality issues management and general GCP guidance.

• Asset-Level Quality Oversight
  • Ensure clinical development plan strategy and asset-level risks are incorporated into study and asset level risk management and oversight to support GCP Compliance
  • Strategically, utilize quality measures/data to monitor asset/study quality and identify potential risks, quality trends, and support state of quality reporting
  • Communicate key quality information across study teams and serve as GCP quality expert to study teams
  • Monitor submission risk and flag major risks for Category Quality Head review and other key stakeholders for review
• Study-Level Risk Management Plan Development and Oversight
  • Oversee study-level quality risk management activities, including driving Study Risk Profile development/maintenance and QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner
  • Develop and present quality point of view at governance and portfolio related meetings
• Inspection Readiness, Preparation and Support
  • Provide Study Team Inspection Readiness (IR) guidance and support to asset teams and pivotal study teams that have a high likelihood of regulatory inspection; lead teams through pre-submission IR deep dive and storyboards
  • Develop and maintain inspection readiness tools and processes
  • Coordinate GCP inspection support activities including requests for dossiers, pre-inspection requests, during inspections and written responses to findings
• Business Development
  • GCP quality representative of the PRD due diligence team for business development opportunities
  • GCP quality representative on integration teams responsible for identifying key quality risks and proposed mitigations and incorporate into study level risk planning
  • Provide strategic input to risk-based quality approaches
  • Perform Quality Integration activities including representing quality functional lines at integration/workshops and developing quality project plans for GCP business deal activities
• Escalation, Communication, and Governance
  • Develop and present quality related information at governance and/or operational meetings
  • Advise asset/study team on appropriate escalation pathways for quality concerns
  • Communicate key quality information across asset/study and serve as asset quality expert
  • Lead asset level/study level quality risk planning activities

• A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:
• BS: 10+ years or equivalent
• MS/MBA: 7+ years or equivalent
• Ability to build strong network/knowledge/relationships with internal/external stakeholders
• Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Familiarity with the relevant key therapeutic area(s)

• Oncology experience strongly preferred
• Advanced clinical trials experience, especially operational processes and/or systems
• Strong interpersonal skills, ability to influence, engage leaders and establish and maintain excellent working relationships across…