About Lilly
We unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Job Position
The GCP Medical Auditor role is office-based at the Lilly Kobe ・Tokyo affiliate office.
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Position Brand Description:
The Global Quality Auditor provides quality assurance through internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance, and consumer information quality (CIQ) for Lilly. They ensure that Good X Practices (GxP) operations conducted or sponsored by Lilly adhere to company standards, policies, procedures, and practices, as well as current regulatory requirements and expectations.
Key Objectives/Deliverables:
1. Scheduling, preparing, conducting, and reporting Global Quality Auditing and Compliance (GQAAC) audits and assessments of GxP operations, both internally and externally.
2. Participating in or leading the risk assessment of GxP operations in support of generating the GQAAC risk-based annual audit plan.
3. Apropriately escalating any compliance issues.
4. Meeting the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
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Global Quality – Business Related Responsibilities:
1. Participating in or leading the preparation and/or review of standards, policies, procedures, and guidelines used to establish quality requirements.
2. Participating in or leading the preparation of organizational metrics and trending of audit findings.
3. Providing audit-related advice to GxP operations on the interpretation of corporate and regulatory GxP requirements related to quality management.
4. Establishing and maintaining relationships with relevant business areas and regulatory authorities.
5. Providing technical expertise in identifying, formulating, assembling, and delivering quality and compliance education to customers.
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Personnel Development:
1. Maintaining good interpersonal and communication skills with auditees and business areas.
2. Completing required training for the roles identified in the Individual Training Plan (ITP).
3. Being continually aware of current industry trends and regulatory agency interpretation of GxP requirements.
4. Seeking self-development in GxP areas.
5. Participating or leading divisional improvement efforts.
6. Supporting training and qualification of other auditors.
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Minimum Requirements:
1. Relevant experience within the GCP medical area at Lilly or within the pharmaceutical environment.
2. Good oral and written communication skills in English.
3. Ability to communicate verbally and written like a native Japanese.
4. Experience working with Third Party Organizations.
5. The ability to understand detailed scientific information while remaining anchored in the