JOB SUMMARY

• Develops, maintains, and oversees the GCP quality management system (QMS) and associated strategy, processes, tools, and technologies for clinical development activities in China, consistent with the enterprise-wide GCP QMS strategy in Pfizer Research & Development (PRD).
  • Implements and oversees the QMS strategy in China.
  • Owns and maintains the Level 1 GCP Quality documents, including the local GCP Quality System Manual.
  • Drives consistency and compliance with regulatory expectations and company standards through quality planning, monitoring, control, and improvement activities and ensures any country-specific requirements are aligned with the enterprise-wide GCP QMS strategy,
  • Acts a point-of-contact (POC) and subject matter expert (SME) for clinical quality requirements and activities in China, emphasizing Quality-by-Design (QbD) principles,
  • Chair/co-Chair of the China Quality Oversight Committee which is a sub-committee of the GCP Quality Oversight Committee.
• Owns and manages the strategy and activities related to inspection readiness for clinical development conducted in China, partnering with local Medical Quality Assurance to prepare for and manage GCP regulatory inspections.
• Owns and manages the strategy and activities related to audit response management, serving as the primary point of contact for PRD, Clinical, and vendors for GCP-related process and vendor audits in China.
• Assesses and ensures, in partnership with the global Vendor Quality Management Lead, that clinical trial vendors used locally have the appropriate GCP quality system components and capabilities in place to meet internal and external/Regulatory quality standards.
• Drives the development of annual Quality Plans for Development China functions and the China clinical trial portfolio and associated key vendors. Leads systematic quality oversight, control, and improvement efforts to achieve and maintain quality standards.
• Oversees GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities.
• Plans, prepares, and reports on Quality and Compliance Assessments to identify areas for further analysis and remediation.
• Acts as an SME/ leader in driving adherence to GCP and Pfizer’s CMCD environment.
• Partners with global Quality Culture Program Lead to develop and implement appropriate GCP quality-focused programs for China.
• In support of China Clinical Activities
  • Leads the strategy for the development and maintenance of local procedural documentation, as required.
  • Develops customer facing capabilities (e.g. GCP and CRA Certification training capability as well as Clinical Processes, CI, CQM Inspection Readiness and Metrics Support) in DOC to support all Clinical Trial disciplines in China, including both Front End and Back End/ Biometrics disciplines (i.e. Clinical Sciences, Clinical Trial Management, Clinical Data Services, and Clinical Programming and Writing)
  • Leads training strategy development and execution based on needs and sourcing availability.

JOB RESPONSIBILITIES

• Leads the China CDQ & DS function by setting the standard for collaborative leadership, delivery of project commitments and customer satisfaction.
• Co-leads the China Quality Oversight Committee, partnering with the Medical Quality Assurance lead in China.
• Leads inspection readiness activities for clinical development conducted in China.
• Partners with local Medical Quality Assurance to prepare for and manage regulatory inspections of the GCP quality system.
• Leads audit response management, serving as the primary point of contact for Corporate Audit, DevOps, Clinical, and vendors for GCP-related process and vendor audits.
• Leads local GCP vendor quality assessment to ensure that selected vendors have the capabilities to meet internal and external quality standards.
• Leads the development of annual Quality Plans for Development China functions and the China clinical trial portfolio and associated key vendors. Leads systematic quality oversight, control, and improvement efforts to achieve and maintain quality standards.
• Supports GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities.
• Plans, prepares, conducts, and reports on Quality and Compliance Assessments to identify areas for further analysis and remediation.
• Provides management oversight for the Shanghai based CDQ & DS functions.
• Ensures that adequate Operational quality control metrics are in place.
• Champions, maintains and instills a global perspective of GCP quality with a focus on strategy and standardization through Clinical Processes, SOPs, training, quality risk management and GCP compliance management.
• Partners with global Quality Culture Program Lead to develop and implement appropriate GCP quality-focused programs for China.
• Develops people, including recruitment, retention and career development strategies for China CDQ & DS staff. Mentors key staff as identified by succession plans.
• Ensures appropriate Global/ Local leadership interactions/ forums are identified and implemented in order to drive China CDQ & DS staff engagement and retention
• Provide line leadership of China CDQ & DS, such as team member performance management, individual development planning, routine oversight and management of the team, ensure team deliverables are achieved, and sustain an engaged and motivated organization
• In support of China Clinical Activities. As appropriate represents GCP and site teams/task forces related to the development and implementation of SOPs and Training.

QUALIFICATIONS / SKILLS

• A scientific or technical degree; MS / MD / PhD is preferred.
• Demonstrated experience in GCP Quality.
• Business degree and/or coursework is desirable.
• Demonstrated knowledge of clinical research processes and GCP regulatory requirements (local and global); abilityto gain command of process details.
• Demonstrated success/results in prior scientific/administrative management roles.
• Knowledge and demonstrated success in training, curriculum development and implementation.
• Knowledge of organizational development principles and demonstrated success in developing and implementingorganizational development strategies.
• Demonstrated ability to manage complex projects and cross-functional processes required.
• Understands state-of-the-art technologies to evaluate and leverage them into improved business processes.
• Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget.
• Demonstrated ability to understand the principles of CI methodologies to support the development and implementation of BPIs.
• Demonstrated ability to provide objective advice and assistance relating to the strategy, structure, management and operation of a team or functional line to achieve their goals and objectives.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Head of Development China
• Matrix relationship to the Head of SOP & Training
• Peer with other members of GCP Quality LTs
• Strong interface with Medical Quality Assurance Lead for China

RESOURCES MANAGED

• Manages resources (ie, 15-20 member team & contract resources) and budget for the China CDQ & DS function.
• Influences China CDQ & DS functional leads to identify and deliver expertise to help drive the successful execution of GCP
• Influences site based functional lines to identify and deliver expertise for the implementation of global processes.

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