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 regulations
• Assesses compliance of Vendors against applicable government agency GCP, GLP, GCLP, Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer policies and procedures
• Independently 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 needed
• Actively supports regulatory inspections as needed
• Serves as a strategic partner with relevant R&D China team to support local regulatory activities, including inspection readiness, self-assessment process
• Advises Pfizer R&D in China on outcomes of complex audits and provides input to process improvement activities
• Executes audit strategy and leads/supports process audits
• Acts as a reviewer of audit reports from outsourced or routine audits
• Assesses audit plans and quality metrics to identify potential areas of risk
• Identifies and drives process improvements
• Delivers awareness sessions with oversight by manager on various GxP topics internally and externally
• Drives interactions with RQA colleagues at other Pfizer locations to ensure consistency in application of RQA strategy and to promote standardization of auditing approach within RQA
• Actively engages in discussions to determine impact of changing needs of the regulatory environment
• Works with RQA colleagues on cross GxP audit plans as required
• Advises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities
• Exemplifies Pfizer value behaviors and promotes Quality & Compliance culture. i.e. actively support China Quality and Integrity Forum and other quality culture activities.

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

• 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 controls
• Actively engages in appropriate activities and independently providing RQA and Pfizer China R&D with influence and recommendations to meet changing GxP business needs