R&d Clinical Quality Assurance Senior Specialist

Merck Merck · Pharma · Tokyo, Japan

This role is a Senior Specialist in R&D Clinical Quality Assurance at Merck, focusing on ensuring data integrity and compliance with global regulatory requirements in clinical trials across the APAC region. The primary responsibilities include conducting GCP audits, preparing audit reports, collaborating with various teams to resolve observations, and supporting the overall quality assurance processes within clinical development.

What you'd actually do

  1. APAC region (Japan included) GCP audits, mainly medical institution audits, are in charge. Cooperation with suppliers, Third party collaborations, and due diligence activities may be included.
  2. Prepare, conduct QA audits in the APAC region (Japan included), create audit reports, communicate results to relevant QA management and external relevant stakeholders (e.g., Clinical Operations), and resolve QA observation by collaborating with various teams to ensure corrective and preventive actions are applied.
  3. Lead specific tasks and operations within the team, prioritize time and effort towards critical deliverables, and produce high-quality work.
  4. Contribute to the overall goals of the team by excelling in individual roles and proactively working to improve one's own skills.
  5. Influence, collaborate, and coordinate with other colleagues.

Skills

Required

  • BS/BA degree or equivalent qualification, or experience in a related field, with familiarity with the key activities and fundamental skills required for this role.
  • Approximately 5+ years of hands-on GCP (Clinical Trials) auditing experience in a pharmaceutical company or CRO, including both On-site and Remote audits.
  • Hands-on knowledge of ICH-GCP, Japanese Pharmaceuticals and Medical Devices Act (PMD Act), and clinical trial regulations in major jurisdictions (e.g., FDA, EMA).
  • Knowledge of clinical development. Including protocol development, ethics committee review, informed consent, subject selection and enrollment, data collection and management, monitoring, investigational drug management, serious adverse event handling, data cleanup, and study report writing, throughout the entire clinical trial process.
  • Hands-on experience in audit planning, audit execution, audit report writing, and proposing and following up on corrective and preventive actions (CAPA).
  • Experience in global teams or multinational projects, or a strong desire and adaptability to work in a global environment.
  • Fluent Japanese language skills are required. The successful candidate must be able to communicate accurately and professionally in Japanese, both spoken and written, with external stakeholders (including investigators) and internal teams.
  • Ability to participate in and lead meetings in English. Ability to handle email correspondence and create documents and presentations in English. Ability to create audit reports in English and experience conducting audits in English, or the ability to do so. Ability to conduct audit debriefings.
  • Accountability
  • Audits Compliance
  • Business Partner Support
  • Clinical Quality Assurance
  • Clinical Reporting
  • Data Analysis
  • GCP Auditing
  • Investigative Auditing
  • Process Audits
  • Quality Assurance (QA)
  • Quality Risk Management
  • Validation Processes
  • Vendor Audits

What the JD emphasized

  • GCP audits
  • clinical trial data integrity
  • regulatory requirements
  • APAC region (Japan included)
  • APAC region (Japan included) GCP audits
  • APAC region (Japan included) for QA audits
  • GCP (Clinical Trials) auditing experience
  • ICH-GCP
  • Japanese Pharmaceuticals and Medical Devices Act (PMD Act)
  • clinical trial regulations
  • clinical trial process
  • clinical auditing experience
  • auditing experience
  • auditing
  • audits