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Role reports to：
Quality Head Japan位置：
Asia Pacific, Japan, Tokyo-To, Chiyoda工作地點：
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Position Summary
Responsible for management of Make Quality to achieve Quality & Compliance objectives laid down for External Manufacturers (EMs) and Suppliers in line with Strategic plans aligned with the Management with customer focus. The positions reports to Quality Head Japan.
• Manage the external manufacturing sites assess Quality systems effectively through internal audit and Management review and implement corrective/preventive, improvement actions as appropriate.
• Support manufacturing sites in the investigation, evaluation and implementation of actions to eliminate root causes of non-conformances.
• Establish and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business.
• Provide disposition for non-compliant products and assures escalation of potential quality or compliance problems to local/regional leader.
• Ensure effective risk management processes are implemented to prevent unanticipated failure modes.
• Enable product localizations/New product launches to deliver market appropriate product offerings.
• Ensure quality processes are followed across the external network by enforcing Quality Agreements, establishing product specifications and deploying quality assurance procedures meeting Kenvue requirements.
• Ensure external partners remain compliant to health authority regulations and other country’s statutory requirements, such as CSAR.
• Lead people development objectives and support programs to ensure availability of competent people and talent retention. Ensure opportunities and developmental programs are consistently provided to deserving candidates.
• Cascade global strategic initiatives and drive deployment of Global standards to the External network for EMs/Suppliers. Ensure adequate gap assessments have been conducted, and gaps are closed with definite timelines.
• Manage the process for reporting key KPIs by collecting, analyzing and summarizing information and trends including improvements expected with external partners and align proactive remediation plans in accordance with business risks.
• This individual has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product sourced from EMs.
• Report any critical issues or potential quality issues should be reported to total sales & manufacturing license officer in timely manner and conduct immediate actions based on orders from total sales and manufacturing officer.
• Construct good relationship with pharmacovigilance and all related sections to conduct smooth handling for products quality issues.
• People management including each carrier planning / resource planning. Direct Reports: 3
Major Duties & Responsibilities
Approximate Percentage of Time: Tasks/Duties/Responsibilities
100% Total
30%: Achieve all OKRs defined by WW, Regional and local management and ensure timely communication/escalations to Management.
20%: Ensure compliance of manufacturing plants and LOCs to Quality Policy, Enterprise standards, GMP, appropriate regulatory authority and other quality & compliance standard requirements.
20%: Ensure adequate resource in all areas of Quality & Compliance (Quality Systems, Plant QA, Laboratories, and LOCs ), Ensure development plan for all staff allowing them to achieve their highest potential and succession/development plan in place for high potential employees and critical positions.
20%: Oversee overall implementation of Quality & Compliance initiatives related to Proactive Quality/Zero Defect program in the cluster.
10%: Liaise with other sites or markets importing products from other countries/continents on their requirements, and the other site Technical teams to ensure immediate resolution of technical issues.
Other Duties
• Meet set goals on Quality OKRs
• Compliance to Quality Purpose, Global standards, WW Procedures and Guidelines, Regional QSPs and local SOPs
• 100% completion of Management Reviews
• No delays/issues in new product launches and other initiatives due to Quality
• Development of Quality & Compliance organization and success of direct reports
• Adequate support, both Quality & Compliance and Technical Team, provided on key Business issues/initiatives
• Achieve Zero Defect goals
• Deliver the GRC, ISO, EHS, MRA and manage Halal related activity
Percentage Traveled: 20% (Japan)
Key Working Relationships
Internal: Make, Supply Chain, Commercial, RA, R&D, MST, Med safety
External: Local Health Authorities (PMDA, Tokyo pref.)
What we are looking for:
Experience
• 5+ years related experience in Pharmaceutical Industry and/or Cosmetic Industry in Quality Management.
• Minimum of 3 years of active management experience including direct supervision
Knowledge, Skills and Abilities
• Strong leadership, collaboration and interpersonal skills, tenacity and perseverance
• Strong ability to influence others’ decisions that will benefit the company as a whole
• Strong knowledge of GMPs, WWSPs, QSPs and other Quality Systems and Guidelines
• Knowledge and awareness of regulations of local and those of related countries/regions
• Results oriented and able to independently create and deliver
• High energy, self-starter and entrepreneurial
• Business level of English both verbal and written.
• Sound decision-making and problem-solving skills
Preferred Qualifications
Preferred Minimum Education: Bachelor’s or Master’s Degree in Pharma / Chemistry / Life Science or Engineering
Preferred Area of Study: Science/Pharmacy/Engineering
Preferred Related Industry Experience: Cosmetics or Pharmaceuticals
Preferred Knowledge, Skills and Abilities: MS Office (Word, Excel, Power Point, etc.)
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