Functional Quality Lead - Statistics / Statistical Programming and Analysis
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective Center for Standards & Data Quality (CSDQ) team in Global Biometrics & Data Management (GBDM) organization. You will be responsible for activities involved in maintaining a quality line-of-sight for process and technology associated with Statistics / Statistical Programming and Analysis (SPA) activities. You will ensure that Statistics and SPA processes and procedures ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in interpreting policies, and with this focus, as a Functional Quality Lead (FQL) – Statistics and SPA, your deep knowledge of level one quality issues and risk areas within clinical research and development across clinical trial business process areas will help us achieve Pfizer’s mission globally. You will work in partnership with roles in Clinical Development & Operations, the Quality Center of Excellence, and Regulatory Quality Assurance to ensure Statistics and SPA functional quality oversight, drive quality risk management activities across the Statistics and SPA line, and will be instrumental in ensuring that Statistics- and SPA-specific information is appropriately incorporated within the GCP QMS. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on as a point person to stakeholders within and outside of GBDM for quality risk management, quality issues management and general GCP guidance.
As an advisor and an expert, you will be able to build and leverage constructive relationships across the organization to achieve GBDM’s goals and objectives. You will be entrusted with developing Pfizer’s strategies for a portfolio of products and projects.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
How You Will Achieve It
Level 1 GCP Quality for Statistics / SPA:
Provide single point of accountability to clinical teams or colleagues within Statistics / SPA for GCP advice and guidance
Strategically utilize quality and compliance data to monitor Statistics / SPA quality and recognize potential risks and issues. Ensure Statistics / SPA extended leadership team(s) are aware of risks, issues and general quality state of performance as it relates to people, process and technology. Analyze and interpret data from multiple sources to drive quality assessments
Partner with Analytics and Reporting on the development of quality metrics
Provide Level 1 Statistics / SPA quality expertise on Significant Quality Event (SQE) investigation teams in collaboration with Statistics / SPA business process owner(s), as needed
Design and execute quality compliance assessments within Statistics / SPA and drive learnings across the organization
For persistently red metrics, guide project teams or Statistics / SPA colleagues through a CAPA discussion identifying appropriate actions/remediation
Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities
IQMP Oversight (Integrated Quality Management Plan) Statistics / SPA process level including integration within the Quality Management System (QMS)
Oversee Statistics / SPA quality risk management activities (including IQMP activity)
Drive consistent implementation of IQMP across Statistics / SPA
Facilitate IQMP development to ensure that Statistics / SPA GBDM colleagues:
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
Assess QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.
Evaluate the quality of approved IQMPs through IQMP effectiveness reviews and/or IQMP QC reviews
Utilize QMS information, and integrate findings back into QMS, share learnings across FQL team
Provide feedback to IQMP BPO to continuously improve IQMP approach
Escalation, Communication, and Governance
Develop and present quality point of view at governance meetings
Guide Statistics / SPA on maintaining appropriate escalation pathways for quality concerns
Escalate/communicate quality issues to:
Quality Center of Excellence (QCOE)
Regulatory Quality Assurance (RQA)
Governance committees (e.g. GCP QOC, RDM QCC)
IPLT /Process Quality Leads for process level issues
Ensure continuous improvement feedback on business processes to BPOs both within GBDM as well as across GPD
Communicate key quality information (e.g. inspection/audit learnings) across Statistics / SPA and serve as Statistics / SPA quality expert
Inspection Readiness and Preparation
Provide Statistics / SPA Inspection Readiness (IR) guidance and support
Participate and guide Statistics / SPA team members with inspection preparation, conduct and response activities
Support Statistics / SPA team members and business process owners (BPOs) during inspections.
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 – 5 years or equivalent
Ph.D./MD – 5 years or equivalent
Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines
Expert knowledge, experience and expertise in clinical trial development, and operational 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.
Ability to build strong network/knowledge/relationships with internal/external stakeholders
Familiarity with Statistics / Statistical Programming and Analysis
Advanced clinical trials experience, especially operational processes and/or systems.
Advanced Quality Management experience including use of metrics to drive quality and compliance
Excellent understanding of Pfizer processes and SOPs
Demonstrated experience engaging leaders and establishing stakeholder relationships
Strong influencing skills with ability to influence a broad range of global stakeholders.
Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization
Appreciation of diverse needs of different regulatory requirements of different sites and countries
Excellent communication skills adaptable to meet the needs of diverse stakeholder groups
Ability to balance and prioritize a diverse and demanding workload
Quality related experience including working knowledge in areas of:
Quality and compliance management
Root Cause Analysis
Metrics development and utilization
Inspection Readiness, Inspection conduct and CAPA response process
ICH GCP, and Regulatory obligations
Spotfire and Excel skills/experience
Ability to implement strategies using coordinated and transparent metrics to track and manage compliance
Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement
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.
Ability to design and perform complex data analysis
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