Vision CQ Transportation Quality Specialist - APAC & Japan

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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Mumbai, Maharashtra, India, Shanghai, China

Job Description:

Purpose:

The Vision CQ Transportation Quality Specialist - APAC & Japan provides quality oversight and subject-matter support for inter-regional transportation activities impacting APAC and Japan. The role helps ensure that transportation operations meet applicable quality, regulatory and business requirements and that transportation risks and issues are managed effectively.

Working within Vision Commercial Quality, the position collaborates with regional and global stakeholders, internal functions and external partners to support compliant, reliable and continually improving transportation processes.

The role also supports governance through the provision of Vision-specific information and, where required, contributes to cross-segment transportation investigations with MedTech and Innovative Medicine while retaining accountability for Vision activities.

Key Responsibilities:

• •Provide operational quality oversight for inter-regional transportation activities impacting APAC and Japan, partnering with regional Commercial Quality, Transportation Operations, Supply Chain, Procurement, carriers, control towers and logistics providers.
• •Lead or support transportation-related investigations, nonconformances, CAPAs, deviations, change controls, complaints, product-impact assessments, effectiveness checks and associated quality records through timely closure.
• •Assess and coordinate the resolution of transportation incidents, temperature excursions, damage, contamination, losses, mis-deliveries, seal issues and service failures; escalate material risks in accordance with established processes.
• •Support transportation supplier quality activities, including carrier qualification, quality agreements, supplier audits, performance reviews, corrective-action follow-up and remediation.
• •Support transportation lane and route qualification, lane mapping, shipping-route verification, transportation risk assessments, temperature-control qualification and network changes.
• •Provide quality support for new product introductions, transfers, business-continuity activities and other projects that change transportation routes, providers, systems or operating processes.
• •Build, maintain and report transportation quality metrics, dashboards, scorecards and trend analyses; identify emerging risks, recurring issues and improvement opportunities.
• •Maintain complete, accurate and retrievable documentation and evidence packages to support internal audits, supplier audits, health authority inspections and notified-body assessments.
• •Contributes to process simplification, harmonization, training, communications and capability-building initiatives as transportation responsibilities transition into Vision CQ.
• •Prepare and validate Vision-specific transportation quality data, metrics, trend analyses, risks and investigation insights for use in governance meetings and management reviews.
• •Provide clear Vision-specific supporting information and subject-matter input in response to governance requests, ensuring that Vision transportation issues, trends and regulatory considerations are accurately represented.
• •On occasion, work with MedTech and Innovative Medicine quality colleagues on cross-segment transportation investigations, contributing Vision-specific evidence, product and lane impact assessments, root-cause input and agreed follow-up activities.
• •Provide technical quality guidance, support workflow execution and contribute to departmental transportation quality priorities; this position has no direct supervisory responsibility.

Qulifications

Experience & Education:

• •A minimum of a Bachelor’s degree is required.
• •Degree concentration in Life Science, Engineering, Technical Business, Quality, Regulatory Compliance, Supply Chain, Logistics or a related discipline is preferred.
• •Minimum five years of experience in a regulated healthcare industry, including medical devices, pharmaceuticals and/or diagnostics, with quality, regulatory compliance, distribution, supplier quality coordination, transportation or supply chain quality experience.
• •Experience supporting transportation quality operations, investigations, CAPAs, quality events, change controls, metrics reporting, trend analysis and cross-functional project activities.
• •Demonstrated knowledge of applicable global regulations and experience collaborating with professionals in a matrixed environment.
• •Experience supporting transportation qualification, supplier quality activities, new product introductions, network changes, remediation and/or quality improvement activities is preferred.
• •Experience preparing accurate operational quality data, metrics, trends and risk information for governance or management review, and collaborating across functions on shared investigations or issue resolution.
• •Previous experience supporting audits or interfacing with regulatory agencies and notified bodies is preferred.

Required knowledge, skills, abilities, certifications/licenses and affiliations:

• •Working knowledge of transportation quality management, Good Distribution Practices, quality management systems, supplier quality coordination, carrier performance, qualification activities, issue escalation and compliant logistics operations.
• •Knowledge of lane and route qualification, lane mapping, temperature-controlled transportation, temperature excursion management, transportation risk assessment and logistics-provider oversight.
• •Demonstrated ability to partner effectively with Transportation Operations, Supply Chain, Procurement, APAC and Japan regional Commercial Quality teams and external suppliers in a matrixed environment.
• •Strong analytical and problem-solving skills, including the ability to use metrics, scorecards and trends to identify risk and drive action.
• •Excellent communication, collaboration, influencing and presentation skills, with the ability to build trust and credibility across Quality and Compliance, Supply Chain, Commercial and external partner organizations.
• •Ability to zoom in and out across strategic, tactical, high-level and detailed perspectives; manage multiple priorities; make complex topics clear; and operate effectively in an ambiguous environment.
• •Ability to prepare clear, accurate and decision-ready Vision-specific data for governance review and to collaborate effectively with MedTech and Innovative Medicine colleagues when supporting occasional cross-segment transportation investigations.
• •Fluent English and Japanese language capability are required, with the ability to communicate effectively with Japan-based stakeholders and support the review or coordination of Japan-related transportation quality documentation.
• •Quality auditing, GDP, project management, supply chain, logistics, Lean or Six Sigma certification is desirable.

Location & Travel requirements:

Location is flexible subject to business and employment requirements, with the ability to support stakeholders a