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Quality Compliance & Standards Lead, RWE Platform
Pfizer - Bothell, WA
posted 2 months ago
About the position
The Quality Compliance & Standards Lead (QCSL) is a pivotal role within the Evidence Generation Team at Pfizer, responsible for ensuring quality oversight in the implementation of research and studies conducted in the global Real-World Evidence (RWE) Platform. This position involves coordinating quality, vendor oversight, and training activities across functions, providing guidance to study teams on safety reporting and compliance, and engaging in audit preparedness and quality event management. The QCSL will work collaboratively with various stakeholders to maintain high standards of quality and compliance throughout the study lifecycle.
Responsibilities
- Collaborate with cross-functional teams to ensure RWE plan strategy and asset-level risks are incorporated into study and asset-level quality oversight.
- Utilize quality measures/data to monitor portfolio quality and recognize potential risks.
- Provide accountability in sourcing strategy, vendor selection, assessment, onboarding, oversight, and performance management.
- Address and triage quality-related questions within Evidence Generation scope.
- Communicate key quality information across asset/study teams and serve as TA quality expert.
- Guide study teams on high-risk activities and ensure timely identification of quality deviations.
- Participate in governance review boards for high-priority assets/protocols.
- Review regulatory submission projects/protocol drafts for compliance with SOPs and regulations.
- Provide quality oversight for non-interventional, low interventional, and collaborative research studies.
- Support study teams in audit and inspection readiness, developing tools and processes for inspection preparedness.
Requirements
- Bachelor's Degree and 10+ years of relevant clinical trial, non-interventional study and/or epidemiologic study experience.
- Master's Level degree (MPH, MS) in a health-related field and minimum 8 years of relevant experience.
- In-depth knowledge of ICH-GCP, research quality/compliance experience, study regulations, and data privacy requirements.
- Experience in SOP evaluation, risk assessment, and quality event processing.
- Experience in audit management and CAPA writing with cross-functional teams.
- Strong project management abilities and multitasking skills in complex processes.
- Excellent interpersonal skills and ability to influence stakeholders constructively.
Nice-to-haves
- Proficiency in SharePoint/Teams
- Proficiency in Microsoft Office applications
- Fluent in English, both written and verbal
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
