Asset Quality Lead, GCP Inspections (Director, Oncology)
BioCT Innovation Commons, Groton, CT, United States
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.
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 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
Basic Qualifications
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)
Preferred Qualifications
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 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 to assess GCP situations and coordinate resolution across partner lines
Excellent knowledge of Pfizer SOPs and quality management processes
Extensive Quality related experience including 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
Organizational Relationships Partners with key stakeholders such as Clinical Development & Operations, RQA, Data Sciences and Analytics, Global Clinical Supply and BPOs.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: Hybrid
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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.
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 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
Basic Qualifications
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)
Preferred Qualifications
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 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 to assess GCP situations and coordinate resolution across partner lines
Excellent knowledge of Pfizer SOPs and quality management processes
Extensive Quality related experience including 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
Organizational Relationships Partners with key stakeholders such as Clinical Development & Operations, RQA, Data Sciences and Analytics, Global Clinical Supply and BPOs.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: Hybrid
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