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Role reports to：
Senior Director Auditing位置：
Asia Pacific, Japan, Tokyo-To, Chiyoda工作地點：
混合你會做什麼
• Executing the corporate’s Regulatory Compliance audit program by, among other duties assigned as deemed applicable, performing, and leading, audits across Internal Manufacturing (IM), External Manufacturing (EM), suppliers and others in Japan and across APAC to assure audit readiness and compliance with applicable government regulations, company standards, policies, quality agreements, international standards and procedures.
• Managing the execution of audit planning, scheduling, site coordination, budget, and employee development.
• Identifying, accurately capturing holistic view of potential compliance risks, documenting audit findings and promptly communicating, and as appropriate escalating issues to senior management.
• Issuing and distributing, in a timely manner, audit results for review by management
• Developing and maintaining effective and collaborative business relationship with key stakeholders and functional department within Kenvue to ensure that the strategic objectives of the corporate audit program are achieved and continuously improving execution and results based on process insights.
• Maintaining current on regulatory requirements changes and responsible for providing recommendations for audit program improvements to effectively assess GxP compliance.
•Supporting the Enterprise Regulatory Outreach group to appropriately influence and interpret requirements of the Regulatory Agencies around the globe.
Regulatory Compliance Focus:
•Provides support to the year’s audit schedule including pre-audit planning, resourcing, scheduling and execution of audits (in-person, remote or using appropriate auditing tools) to ensure the audit program is consistently meeting the objectives of achieving a healthy state of audit readiness.
•Plans audits to fit auditee’s site type, products, technology and potential linkages to other sites.
•Leads and executes audits per said schedule or at the discretion of management based on risk or prioritization deemed necessary and reports via verbal and written communication any outcomes that are in the scope of the audit.
•Immediately escalates significant compliance issues to management capturing description of potential violation, severity and potential impact on the company’s products, systems, processes or consumers.
•Continuously improves technical and interpersonal skills, through training or otherwise, to serve as subject matter expert on Regulatory Compliance matters and help stakeholders improve awareness of potential gaps and opportunities for remediation.
•While in audit, represents the audit team as an engaged partner fostering trust and collaboration to identify strengths and weaknesses, helping the auditee understand their state of compliance and allowing the process to provide the appropriate steps to remediate.
•Support the preparation of metrics and performance data as appropriate, based to support identification of emerging compliance trends. This will enable providing holistic view of potential compliance risks across the company and help deploy countermeasures strategies to prevent impact and sustain state of compliance.
•Supports the department effort to maintain the yearly budget.
•Continuously evaluates Regulatory Compliance procedures identifying improvements based on input from the changing Regulatory requirements, emerging trends, voice of customer and audit outcomes, changes to product, technology portfolios of the company, etc.
What we are looking for
Qualifications: A minimum of bachelor’s degree in science, engineering, or another related field
Experience: Conducting or exposure to Quality or Regulatory Compliance auditing in a global regulated healthcare environment. Experience in Quality and Regulatory Compliance.
Knowledge, Skills and Abilities:
•Proven ability to conduct and manage GxP audits including development of risk-based audit strategies, audit planning, execution, reporting audit findings in a concise manner.
•Strong Quality and Compliance background with deep understanding of Global Regulatory cGMP requirements.
•Strong knowledge of international regulatory frameworks (FDA, EMA, ISO standards, etc.).
•Knowledge dealing with Worldwide Health Authorities inspections and their approaches and how to effectively respond to their observations.
•Strong communication skills and ability to quickly build credibility with Operations, Quality and Compliance stakeholders.
•Excellent analytical, problem-solving, and risk assessment skills.
•Strong written and oral communication skills with individuals and groups at all levels of the company.
•Ability to identify and take in the vital points of the audit and make big picture decisions and author appropriate observations.
•Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up.
•Strong understanding of all requirements for compliant drug/ device/ cosmetic/ dietary supplement manufacturing, including facilities, equipment, documentation, testing, and product flow.
•Knowledge in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles/tolls and their application.
•Ability to work independently and manage multiple audits simultaneously.
•Fluency in both Japanese and English
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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