• QA/Regulatory Spec IV

    Job Location(s) JP-Tokyo | JP-Osaka | SG-Singapore | KR-Seoul
    Job Number
    Job Category
    Hidden (23502)
    Position Type
  • Job Overview

    The Sr. Auditor II role is responsible for leading internal and external regional and global QA audits per Standard Operating Procedures and Master Audit Plan, assuring that audited systems, processes and their outcomes comply with applicable international and national regulations and guidelines, and fulfill client and Covance requirements. The position assures that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.


    Essential Job Duties:


    Lead audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards


    • Leads complex audits (e.g., directed, process, systems, office)
    • Provide suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
    • Proactively identifies and leads process improvement activities / SOP updates
    • Hosts client audits and able to support regulatory inspections
    • Leads and/or participates in special projects
    • Represents Audit QA on project teams and other internal forums
    • Trains and mentors junior QA Audit staff / support on-boarding of new personnel



    • University/college degree BA/BS (life science preferred),or equivalent
    • Thorough knowledge, understanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
    • Knowledge of the drug development process from the perspective of a contract research organization
    • Business level of Japanese and English




    Minimum Required:

    • 5 years CRO/Pharmaceutical experience
    • 4 years in a GXP quality role, including at least 2 years in a GCP quality role required

     Competencies Required:

    • Excellent written and oral presentation skills
    • Excellent organization and planning skills and attention to detail
    • Proven interpersonal skills
    • Demonstrated ability to handle multiple competing priorities across clinical operating unit
    • Ability to function as a member of a global clinical team



    • Core and Leadership Competencies: Focus on clients, Works well with others, Develops self and team, and Gets it done


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