GMP / GDP Audit Manager Consumer Healthcare Japan

    • Tokyo, Japan

Site Name: Japan - Tokyo - Akasaka
Posted Date: Mar 3 2020
Are you energized by a highly impactful quality role that drives process improvement and broad stakeholder engagement? If so, this Third-Party Quality manager role could be an ideal opportunity to explore.

Job Purpose:
Quality Audit and Compliance (QAC) performs and manages GMP compliance audits of Consumer Healthcare Supply Chain (SC) sites, R&D Sites, R&D and SC Suppliers, GSK CH Local Operating Companies (LOCs), Third Party Contractors supplying CH SC and/or R&D, Logistical Service Providers (LSP), Multi-Market Warehouses and Distribution Centers.

This role reports into the Director of GMP Audit, with the primary purpose to perform and manage GMP and GDP compliance audits of CH SC sites, Local Operating Companies (LOCs) and related central functions, Third Party Contractors (TPCs), R&D GMP Contractors and Logistic Service Providers (LSPs) (includes Repackers, Distributors and Transporters). Audit Managers may also support for cause audits on an as needed basis.

The job exists within the central Quality organisation, to ensure the mandated GSK Quality Management Systems requirements are met and that GMP and GDP compliance is met.

The role holder will manage multiple stakeholders across R&D, Logistics and Supply Chain and using an active mindset, will generate creative solutions for technical problems.

The role holder will ensure that risk is appropriately managed.

Key Responsibilities:

  • Prepare for, conduct and manage GMP and GDP compliance audits of scheduled auditees utilising a risk-based approach to audit scope and depth.
  • Identify and document site gaps to GSK Quality Management System and applicable cGMP/GDP requirements.
  • Ensure effective audit preparation, audit conduct and reporting.
  • Preparation of clear concise audit reports that ensure senior management is appraised of the identified risks and that appropriate corrective action plans are implemented.

In addition:
  • Manage the interface with auditees and stakeholders (the latter may include Site Directors, Site Quality Directors, Heads of Support Functions, General & Quality Mgr of Commercial Companies, Manufacturing & Quality Directors of Contractors)
  • Update assigned Quality Risk Model elements
  • Support root cause investigations into serious incidents/product recalls
  • Communicate learning points through Quality Alerts.
  • Promote early visibility of regulatory issues and GSK responses.
  • Update assigned Global QMS Documents and Audit function SOPs
  • The training and coaching of other auditors (by example during audits or through peer review of reports)
  • Support of the Auditor Certification process (either as a trainer or an interviewer)

Additionally more experienced staff may undertake:
  • Management of the interface with senior stakeholders, including Supply Division Heads, Quality Operational Heads and Cluster Leads
  • Management of large elements of the audit process with minimal direction from the Audit Director
  • Leading multi-departmental projects
  • Management of the interface with senior stakeholders, including Supply Division Heads, Quality Operational Heads and Cluster Leads

Typical work output will involve:
  • Entity audits of GMS manufacturing sites and LOCs
  • New Contractor Assessments
  • For Cause audits of GMS manufacturing, LSPs and LOCs as well as third parties
  • Entity audits of Contract Manufacturing sites
  • Audits and assessments of progress against risk mitigation plans or regulatory citation commitments


Experience:
  • Good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, nutritionals, cosmetics and/or foods
  • Proficiency & experience in planning, performing & reporting Quality or Regulatory Compliance audits.
  • Demonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions
  • Demonstrated knowledge and experience in computer system compliance
  • Broad based familiarity with Primary and Secondary manufacturing
  • Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP/GDP compliance
  • Risk management knowledge
  • Understanding and experience of corporate governance processes
  • New Product Introduction requirements
  • Demonstrated application of continuous improvement, change control and risk assessment
  • Serious Incident management with demonstrated ability to resolve quality issues

Education:
BSc in Scientific or Engineering discipline or computer compliance

Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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GSK is a uniquely science-led global healthcare organization on a mission to help people do more, feel better, and ultimately live longer.

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