Sr Manager/Manager, Inspection Management Lead

1日前

Tokyo Pfizer Full time

The Senior Manager/Manager*, Inspection Management Lead supports Pfizer as required by preparing for, organizing and leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor as appropriate).

*The level of this position, Senior Manager or Manager, will be determined by the candidate's experience and qualifications – both levels are described throughout this job posting.

Senior Manager

The Senior Manager Inspection Management Lead supports Pfizer by (as required) preparing for, organizing and supporting/leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners, as appropriate. In addition, the Senior Manager Inspection Management Lead coordinates Pfizer responses to such inspections. The Senior Manager Inspection Management Lead may also provide support for other RQA activities in the region including, but not limited to; quality investigations, external stakeholder engagement, and Quality Management System support.

Manager

The Manager Inspection Management Lead supports Pfizer by (as required) preparing for, organizing and supporting/leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by Health Authorities/Regulatory Authorities (HAs/RAs) in Japan, and pharmacovigilance audits conducted by license partners within Japan, as appropriate. In addition, the Manager Inspection Management Lead coordinates Pfizer responses to such inspections. The Manager Inspection Management Lead may also provide support for other RQA activities in the region including, but not limited to; quality investigations, external stakeholder engagement, and Quality Management System support.

ROLE RESPONSIBILITIES

Leadership

Senior Manager

  • Serves as a member of the Inspection Management group supporting operational RQA strategies, policies and direction for Inspection Management
  • Champions RQA mission and strategies throughout the RQA organization and among customers for efficient delivery of RQA and compliance activities
  • Collaborates with business stakeholders to instill a culture of regulatory compliance and ensures effective and efficient management of inspection activities
  • Serves as a strategic partner to quality/compliance/inspection readiness colleagues for inspection-related activities
  • Interfaces with functional groups within RQA and customers to build knowledge of GCP/PV/GLP regulations and guidelines, and routinely engages in influencing the external environment through appropriate RQA activities (e.g. review of guidelines)
  • Works with RQA functional lines and key customers to understand stakeholder needs

    • Manager

  • Serves as a strategic partner to quality/compliance/inspection readiness colleagues for inspection-related activities
  • Interfaces with functional groups within RQA and customers to build knowledge of GCP/PV/GLP regulations and guidelines
  • Works with RQA functional lines and key customers to understand stakeholder needs

    • Risk/Quality Management

    Senior Manager

  • Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Pfizer
  • Represents Pfizer in external meetings and conferences as required
  • Liaises with relevant SOP and Training groups to promote continuous quality/process improvements based on inspection observations
  • Evaluates inspection reports from various sources (e.g., HAs/RAs, other Pfizer quality groups) to identify issues of potential significance

    • Manager

  • Monitors trends in health authority inspection activities within Japan to proactively identify potential areas of risk for Pfizer
  • Evaluates inspection reports from various sources (e.g., HAs/RAs, other Pfizer quality groups) to identify issues of potential significance

    • Operational Excellence:

    Senior Manager

  • Collaborates with other RQA Inspection Management Leads and quality/compliance/inspection readiness colleagues in the BUs/RUs/Platform Lines for activities related to inspection preparation; Activities include but are not limited to preparation of relevant materials and conducting inspection-related training (e.g., inspection interview technique)
  • Leads and/or supports pre-inspection visits of investigator sites
  • Leads and/or supports management of global HA/RA inspections (GCP/GLP/GPvP, as appropriate) and ensures that roles and responsibilities have been defined and assigned for each inspection; Assumes a leadership role or other supportive roles during the inspection as required
  • Works with members of the inspection team and other colleagues including, but not limited to, Head of Inspection Management, Head of RQA and Legal to ensure optimum responses are provided to address and resolve inspection findings
  • Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs)
  • Coordinates and assists in the preparation, conduct and management of mock inspections as appropriate
  • Develops and maintains policies, standard operating procedures (SOPs), tools, and guidelines as appropriate for preparation and conduct of inspections within Pfizer
  • Prepares periodic summary reports related to Pfizer inspections
  • Ensures that global contact lists, report distribution lists, and tracking lists used for inspection-related activities are updated and maintained
  • Assists in identifying needs for updates to training materials, inspection readiness modules and documents required for the inspection readiness program
  • Inputs inspection information and reports into appropriate RQA repositories and tools
  • Supports complex projects to drive inspection management strategies, policies and direction for Pfizer
  • Engages in and supports the activities of the relevant RQA initiatives as appropriate to ensure alignment in interpretation and dissemination of applicable regulations, guidance, and Pfizer policies and procedures to customers and stakeholders
  • Maintains high level of expertise in international GCP/GPvP/GLP regulatory requirements, and policies, SOPs and project-specific procedures within Pfizer applicable
  • Fosters a work climate/culture within the team that exemplifies the Pfizer Values
  • Takes accountability to communicate relevant and timely information relevant to the RQA LT, other RQA functions and stakeholders

    • Manager

  • Collaborates with other RQA Inspection Management Leads and quality/compliance/inspection readiness colleagues in the BUs/RUs/Platform Lines for activities related to inspection preparation; Activities include but are not limited to preparation of relevant materials and conducting inspection-related training (e.g., inspection interview technique)
  • Leads and/or supports pre-inspection visits of investigator sites
  • Leads and/or supports management of inspections within Japan (GCP/GLP/GPvP, as appropriate) and ensures that roles and responsibilities have been defined and assigned for each inspection; Assumes a leadership role or other supportive roles during the inspection as required
  • Works with members of the inspection team and other colleagues including, but not limited to, Head of Inspection Management, Head of RQA and Legal to ensure optimum responses are provided to address and resolve inspection findings
  • Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs)
  • Coordinates and assists in the preparation, conduct and management of mock inspections as appropriate
  • Develops and maintains policies, standard operating procedures (SOPs), tools, and guidelines as appropriate for preparation and conduct of inspections within Pfizer
  • Prepares periodic summary reports related to Pfizer inspections
  • Ensures that local contact lists, report distribution lists, and tracking lists used for inspection-related activities are updated and maintained
  • Assists in identifying needs for updates to training materials, inspection readiness modules and documents required for the inspection readiness program
  • Inputs inspection information and reports into appropriate RQA repositories and tools
  • Engages in and supports the activities of the relevant RQA initiatives as appropriate to ensure alignment in interpretation and dissemination of applicable regulations in Japan, guidance, and Pfizer policies and procedures to customers and stakeholders
  • Fosters a work climate/culture within the team that exemplifies the Pfizer Values
  • Takes accountability to communicate relevant and timely information relevant to the RQA LT, other RQA functions and stakeholders

    • QUALIFICATIONS

    Senior Manager

    BASIC QUALIFICATIONS

  • Bachelor's degree or equivalent experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered
  • At least 8 years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance
  • Fluency in the English language (written and verbal) is a requirement for this position
  • Experience evaluating and understanding quality standards or their application

    • PREFERRED QUALIFICATIONS

  • Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable
  • Ability to function autonomously in a matrix model and in a team environment
  • Advanced project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus

    • Manager

    BASIC QUALIFICATIONS

  • Bachelor's degree or equivalent experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered
  • At least 3-5 years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance
  • Fluency in the English language (written and verbal) is a requirement for this position
  • Experience evaluating and understanding quality standards or their application

    • PREFERRED QUALIFICATIONS

  • Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable
  • Ability to function autonomously in a matrix model and in a team environment
  • Project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus
    • 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#LI-PFE

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