Quality Compliance & Standards Lead, RWE Platform

$161,600 - $269,400/Yr

Pfizer - New York, NY

Full-time - Senior

New York, NY

Chemical Manufacturing

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 for 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 on study types and safety reporting, and ensuring compliance with regulations. The QCSL will oversee various study types, including epidemiological studies and non-interventional studies, while collaborating with cross-functional teams to maintain high standards of quality and governance.

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 and collaborative research studies.
• Support audit and inspection readiness by developing tools and processes.

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.

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