ROLE RESPONSIBILITIES

Operational Excellence

• Develops audit strategy/plans for studies in China and provides input to RQA Portfolio Leads and the head of RQA CHINA, including selecting and identifying audit entities for China alone studies and China/Global studies.
• Support the head of RQA CHINA in developing and implementing RQA strategy for the region.
• Keeps current with China specific regulatory and inspectional trends and informs/advises/participates in the audit intelligence gathering process, active participation in industry forums
• Ensures all audits are conducted in compliance with Pfizer policies, Standards and RQA procedures, ensures audit outcomes are calibrated and driven to completion, ensures issues are escalated, and ensures holistic remediation plans and sustainability of CAPA
• Leads/Participates on cross functional project teams and shares knowledge and best practices with relevant groups
• Maintains strong relationships with Pfizer R&D China by understanding and contributing to their quality goals
• 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
• support inspections as needed under the leadership of Inspection Management  
• 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
• 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. lead China Quality and Integrity Forum and other quality culture activities.

Leadership

• Acts as a Portfolio Leader for CHINA alone studies and takes the leadership role by continuously improving audit practices, sharing knowledge with RQA China colleagues, and ensuring colleagues are adequately skilled and trained to meet the needs of the business
• Coaches and mentors colleagues including providing training across all audit types and Due Diligence assessments as needed

Quality/Risk Management

• Engages relevant stakeholders in assuring risk factors are identified and communicated
• Challenges, develops and provides data-driven feedback on key risks to RQA China Head and China Quality & Risk Committee (CQRC) and the Pillar quality leadership and business process owners/program owners on a consistent basis
• 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
• Strongly interacts with RQA colleagues at other Pfizer locations to ensure consistency in application of the RQA strategy and to promote standardization of auditing approach within RQA
• Actively engages in appropriate activities and independently providing RQA and Pfizer China R&D with influence and recommendations to meet changing GxP business needs

BASIC QUALIFICATIONS

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
• Expert knowledge of ICH GCP, applicable global regulations, and process/program regulatory and inspectional trends
• Considered expert / thought leader for RQA in specific therapeutic area or specialty (e.g. gene therapy) and/or audit method (e.g. data management, remote trial methodology etc.)
• Demonstrates refined critical thinking capabilities (e.g. Analyzes key information, questions, and problems clearly and precisely, evaluates material with insight, uses inference to reason from given information to important implications and consequences, uses deductive reasoning consistently and with ease)
• Defines continuous improvement strategy and operational improvement opportunities to remove roadblocks
• Ability to identify risks and need for escalation
• Ability to communicate and influence at senior director or VP level
• Has SME capabilities and can represent Pfizer in industry conferences and with stakeholders
• Able to identify correct path for stakeholder engagement
• Experience evaluating and understanding quality standards or their application
• Able to use technology to recognize and interpret business trends
• Provides coaching and mentoring to team members
• Measures performance of group and holds team accountable for internal KPIs
• Grows and develop talent
• Capable of resource management ownership

PREFERRED QUALIFICATIONS

• Master’s or advanced degree preferred
• 10+ years relevant experience (proven leadership and robust experience in auditing or quality management)
• Experience leading audit teams
• Demonstrate experience managing T&E
• Experience growing and developing talent

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