The Senior Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned projects/products/vendors/PCOs. This role is responsible for Good Clinical Practice (GCP), and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

ROLE RESPONSIBILITIES

Operational Excellence

Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable global regulationsAssesses compliance of Vendors against applicable government agency GCP, GLP, GCLP, Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer policies and proceduresIndependently leads/conducts wide range of routine/non-routine complex investigator site audits, vendor audits, and may support Due Diligence assessments with minimal to no oversight - as neededActively supports regulatory inspections as neededServes as a strategic partner with relevant R&D China team to support local regulatory activities, including inspection readiness, self-assessment processAdvises Pfizer R&D in China on outcomes of complex audits and provides input to process improvement activitiesExecutes audit strategy and leads/supports process auditsActs as a reviewer of audit reports from outsourced or routine auditsAssesses audit plans and quality metrics to identify potential areas of riskIdentifies and drives process improvementsDelivers awareness sessions with oversight by manager on various GxP topics internally and externallyDrives interactions with RQA colleagues at other Pfizer locations to ensure consistency in application of RQA strategy and to promote standardization of auditing approach within RQAActively engages in discussions to determine impact of changing needs of the regulatory environmentWorks with RQA colleagues on cross GxP audit plans as requiredAdvises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activitiesExemplifies Pfizer value behaviors and promotes Quality & Compliance culture. i.e. actively support China Quality and Integrity Forum and other quality culture activities.

Leadership

Continuously improve audit practices and share knowledge with RQA China colleagues to meet the needs of the business

Quality/Risk Management

May serve as member of project team with participation in the applicable forums, providing compliance advice and guidance to customers to achieve continuous quality improvement and effective quality controlsActively engages in appropriate activities and independently providing RQA and Pfizer China R&D with influence and recommendations to meet changing GxP business needs

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Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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