Asset Quality Lead, Director - FSP Job at Parexel

Job Description

The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols. With this focus, the AQL role 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.

Job Responsibility

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
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
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 dive and storyboards
Develop and maintain inspection readiness tools and processes
In conjunction with IMQA, coordinate business line GCP inspection support activities including but not limited to requests for dossiers, pre-inspection requests, during inspections and through the development of written responses to findings
GCP quality representative of the sponsor's due diligence team for business development opportunities
GCP quality representative on integration teams responsible for the identification of key quality risks and proposed mitigations and incorporate into study level risk planning
Provide strategic input to risk-based quality approaches
Where appropriate, perform Quality Integration activities including but not limited to: representing quality functional lines at integration workshops or operational workshops, facilitating GCP Quality Integration Workstreams, and developing quality project plans for GCP business deal activities (e.g., integration operations)
Develop and present quality related information at relevant governance and/or operational meetings
Advise asset/study team on appropriate 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

Requirements

A scientific or technical degree is preferred
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
Familiarity with the relevant key therapeutic area(s)
Advanced clinical trials experience, especially operational processes and/or systems
Strong interpersonal skills, ability to influence, engage leaders and ability to establish and maintain excellent working relationships across lines in a matrix organization
Experience of working on global initiatives or project teams
Appreciation of diverse needs of different regulatory requirements of various sites and countries
Extensive knowledge of regulations in order to assess GCP situations and to coordinate resolution activities across partner lines
Extensive Quality related experience including working knowledge in areas of: Quality and compliance management, QC
Root Cause Analysis
Metrics development and utilization
Audit and Inspection conduct
CAPA development and response process
Inspection Readiness
Project/initiative coordination and management skills
Spotfire and Excel skills/experience
Excellent knowledge of client SOPs and quality management processes

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Asset Quality Lead, Director - FSP

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