Senior Analyst - Digital Identification & Traceability

Senior Analyst - Digital Identification & Traceability

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Manager Digital Product Owner DI and T

Locatie:

Asia Pacific, India, Karnataka, Bangalore

Werklocatie:

Volledig ter plaatse

Wat je gaat doen

Who We Are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information click here.

 

What You Will Do 

The Senior Analyst - Digital Identification & Traceability, will play a key role in the Digital Identification & Traceability (“DI&T”) department within the Kenvue Data + Analytics organization. This role will be responsible for scoping and executing GxP validation/Computer System Validation (“CSV”) for key systems to support the Serialization and Track & Trace, Unique Device Identification, and Global 2D barcoding programs. The Senior Analyst – Digital Identification & Traceability will serve as a point of contact and have day-to-day operational leadership with industry work groups, supply chain, regulatory affairs, quality, and other functions in the organization to ensure scoping and execution of our capabilities and compliance with medical device and medicinal drug requirements. The role will support the operational business activities of these digital capabilities to ensure product information complies with regulatory requirements.

Key Responsibilities

·       Lead cross functional coordination of all system validation activities: define testing strategy and execution plan, write test scripts, define & manage UAT/SIT/FIT. Maintain a roadmap of system validation initiatives, requirements, and timelines.

·       Lead complex data sourcing, mapping, and integration projects with internal Technology partners to ensure system connectivity during migrations.

·       Lead and/or support efforts to train and onboard regional/local teams on Digital Identification & Traceability systems and processes.

·       Engage appropriate internal stakeholders (e.g, Commercial, Regulatory Affairs, Supply Chain, Quality, IT, and others) to define, process, and resolve validation issues and compliance gaps. Serve as Digital Identification & Traceability SME for external stakeholders (vendors) to manage roadmaps, issues, and business requirements.

·       Serve as the Digital Identification & Traceability SME on Investigations, CAPAs, and change control on our systems.

·       Support ongoing efforts to understand Serialization and Unique Device Identification regulations and their impacts on our systems and processes. Categorize, prioritize and share intel with internal stakeholders.

·       Partner with regional teams to prioritize regional portfolio for implementations and drive regional/local engagement.

·       Identify technologies to improve operational processes, data quality and customer/regulation compliance.

·       Ensure all Work Instructions and SOPs are aligned for operational excellence and adherence to GxP.

·       Support continuous process improvements for Unique Device Identification and Serialization QMS.

·       Augment and maintain comprehensive metrics to track issues, resolutions, contingency plans, and timelines to communicate to stakeholders.

·       Support global leadership team in activities related to global strategy, tactical actions, and financial management.

·       Identify and lead efforts to deliver value beyond compliance for the business.

·       Work with Organizational Change Management and Communications team members to develop appropriate documents for internal and external stakeholders.

 

What We Are Looking For

Required Qualifications

·       Minimum of a Bachelor’s degree is required. Specialization in supply chain, regulatory affairs, data engineering, or related is preferred.

·       Minimum of 4 years of business experience with at least 3 years of supply chain, digital transformation, regulatory affairs, quality and compliance, or other relevant experience required.

·       Experience working in or with a complex global organization spanning multiple functions is required.

• Experience working with medicines and medical device regulations impacting supply chain operations is required. Experience working with regulations for Serialization for prescription medicines and Unique Device Identification for medical devices is strongly preferred.

• Experience leading GxP/Computer System Validation projects for systems relating to healthcare regulations is required.

• Experience with SDLC/QMS systems (JIRA, XRAY, HPALM, Veeva, TRU, Symphony, etc.) is required.

• Ability to work with both technical and non-technical team members is required.

• Strong critical thinking, with outstanding analytical, influencing, and interpersonal skills are required.

 

 

Desired Qualifications

·       Excellent analytical skills.

·       Excellent communication skills (written, oral and presentation).

·       Experience with complex data sourcing and mapping strongly preferred.

·       Deep understanding of GS1 standards is strongly preferred.

·       Ability/skillset to drive projects through all phases (discovery, implementation, base business support) is preferred.

·       Ability to develop relationships and inspire confidence and trust from internal and external partners at all levels.

·       Strong understanding of life sciences industry, consumer goods industry, and supply chain processes in a regulated environment.

·       Strong management skills to lead and develop team members and influence others in a complex matrix organization.

·       Understanding of end-to-end Supply Chain interactions, interdependencies, and end-to-end business/IT architecture.

·       Ability to understand the cultural and change management requirements and impact inherent in a large, complex organizational change initiative.

• Experience with making data-informed decisions, with concrete examples of outcomes resulting from defining and measuring success.

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