Asset Quality Lead (Director, Oncology)

Role Summary

The Asset Quality Lead (AQL) is responsible for driving GCP quality by maintaining quality visibility for assigned clinical trial programs and protocols. The role brings deep knowledge of GCP quality and risk management to asset and study teams, and partners with cross-functional Clinical Development & Operations to ensure program and study-level quality oversight, drive risk management and inspection readiness activities, and incorporate asset and study-level information within the GCP QMS. The AQL serves as the primary point of contact for quality risk management, quality issues management and general GCP guidance across the study team and other stakeholders. Location: Hybrid.

Responsibilities

• 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 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 guidance and support to asset teams and pivotal study teams with 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 business line GCP inspection support activities with IMQA, including requests for dossiers, pre-inspection requests, during inspections, and 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 incorporating them into study-level risk planning
  • Provide strategic input to risk-based quality approaches
  • Perform Quality Integration activities where appropriate, including representing quality lines at integration/operational workshops, facilitating GCP Quality Integration Workstreams, and developing quality project plans for GCP business deal activities
• Escalation, Communication, and Governance
  • Develop and present quality-related information at relevant governance and/or operational meetings
  • Advise asset/study teams on escalation pathways for quality concerns
  • Communicate key quality information (e.g., inspection/audit learnings) across asset/study and serve as asset quality expert
  • Lead asset-level/study-level quality risk planning activities

Qualifications

• Required: BS: 10+ years or equivalent or MS/MBA: 7+ years or equivalent
• Required: Ability to build strong networks/relationships with internal and external stakeholders
• Required: Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines such as quality/compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and inspection readiness
• Required: Familiarity with the relevant key therapeutic area(s)
• Preferred: Oncology experience strongly preferred
• Preferred: Advanced clinical trials experience, especially operational processes and/or systems
• Preferred: Strong interpersonal skills, ability to influence, engage leaders and establish/maintain excellent working relationships across lines in a matrix organization
• Preferred: Experience of working on global initiatives or project teams
• Preferred: Appreciation of diverse regulatory requirements of various sites and countries
• Preferred: Extensive knowledge of regulations in order to assess GCP situations and coordinate resolution activities across partner lines
• Preferred: Excellent knowledge of Pfizer SOPs and quality management processes
• Preferred: Extensive quality-related experience including working knowledge in areas such as: quality and compliance management, QC; root cause analysis; metrics development and utilization; audit and inspection conduct; CAPA development and response; inspection readiness; project/initiative coordination and management skills; Spotfire and Excel skills/experience

Education

• Scientific or technical degree preferred