The Phase 1 Quality Risk Management Lead is responsible for leading cross-functional activities that sustain, control, and improve Pfizer's end-to-end clinical trial Quality Risk Management (QRM) process across Pfizer's Phase 1 programs. This includes developing and maintaining process control documentation, utilizing analytical tools, analyzing process control/effectiveness data, identifying and responding to insights from the data, and assessing the effectiveness of systems associated with QRM process execution and oversight. The role is also responsible for analyzing systemic performance and identifying and remediating areas requiring improvement.

In addition, serving as an expert in risk management, the QRM Lead will ensure that the Phase 1 Quality Risk Management Plans are high quality documents that capture and mitigate potential risks that are important in relation to the safety, rights, and wellbeing of trial participants, to the reliability of trial results, and to the compliance with the investigational plan have been identified and successfully controlled. In doing so, the QRM Lead will lead regular interactions with clinical study team members, CDQ LT members, , BT, IM and others to improve the effectiveness of the Quality Risk Management program in support of GPD/WRD performance.

RESPONSIBILITIES:

• IQMP Development and Oversight (Integrated Quality Management Plan) across Phase 1 studies including integration within the Quality Management System (QMS)
  • Oversee study-level quality risk management activities (including IQMP activity)
  • Drive consistent implementation of quality risk management processes across study teams
  • Facilitate IQMP development to ensure that study teams:
    • Identify factors that are critical to quality and pre-specify appropriate quality metrics, and
    • Identify high priority risks to quality and prospectively implement appropriate mitigation plans
  • Ensure that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.
  • Ensure that Quality Risk Management Plans are high quality documents that capture and mitigate potential risks that are important in relation to the safety, rights, and wellbeing of trial participants, to the reliability of trial results, and to the compliance with the investigational plan have been identified and successfully controlled
  • Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CDQ team
• Identify areas to improve QRM process operational efficiency, effectiveness, and integration with regards to end to end clinical trial design and execution processes. Plan and lead operational execution of process improvement initiatives.

* Lead cross-functional teams that are associated with management of the QRM process and ensure appropriate management, control, analysis, remediation, and documentation

* Lead execution of QRM process control plan - Identify and analyze process control issues; drive escalation, remediation and follow up to completion as needed - Lead QC of process metrics data and coordinate with stakeholders to ensure compliance

* Lead execution of Quality Measures Oversight and Remediation control plan efforts

• Identify and analyze process control issues; drive escalation, remediation and follow up to completion as needed
• Lead analysis of data to inform portfolio and vendor quality oversight
• Partner with eQRM and RMT system administrators to provide business user guidance and to resolve issues
• Ensure that business utilization of QRM process related systems is effective and efficient to achieve the desired strategic outcome
• Identify areas for process-system interface improvement and ensure partnership to achieve objectives

QUALIFICATIONS

* BS in a scientific or technical field of study and 10 years of relevant experience, with at least 5 years in clinical development, process quality or risk management.

* Detailed knowledge of clinical trial operational processes and supporting systems and tools

* Detailed knowledge of data and reporting systems

* Effective verbal and written communication skills in relating to leaders, colleagues and associates both inside and outside the organization

* Experience working across multiple levels in an organization

* Experience using data to drive solutions to business challenges

* Experience working with business technology through development and delivery of electronic solutions

SKILLS REQUIREMENTS:

* Track record of delivery

* Strong organizational skills

* Strong facilitation and presentation skills

* Able to work effectively across divisional, functional, site and CRO boundaries

* Able to work in ambiguous situations to identify and resolve complex problems

* Excellent collaborator able to partner across stakeholders

* Contributes to a learning environment by sharing knowledge and best practices within and across the organization

Additional Details:

• Pfizer US Exempt Grade 11

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