Senior Specialist Quality Assurance / PV Audit

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Job details

Company overview

We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people's health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

Responsibilities

• Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
• Activities may include GCP and/or PV related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations and due diligence activities.
• Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
• Promotes standardization of auditing approach within QA.
• May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
• Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
• Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
• Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
• In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
• In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
• Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and line manager.
• Provides inspection management support as appropriate.
• Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
• Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.

Requirements

Education/Experience:

• BS/BA degree in relevant area with significant experience in field and experience in the pharmaceutical industry including experience conducting a broad range of audits.

Mandatory Experience:

• Either or both PV related job experience and/or PV audit experience in pharmaceutical industry
• English communication skills: reading, writing, speaking and listening abilities are required.

Salary

8 - 10 million yen

Location

Tokyo