External Manufacturers Quality Assurance Lead

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External Manufacturers Quality Assurance Lead
Role reports to: EM Quality Head EMEA
場所: Europe/Middle East/Africa, Italy, Lazio, Rome
勤務地: ハイブリッド
What you will do
The EM QA Lead is responsible for providing Quality and Compliance (Q&C;) leadership throughout the lifecycle management of the Kenvue External Manufacturers (EM) within the EMEA portfolio, including continuous Q&C; oversight, new product introduction (NPI), lifecycle management (LCM) projects and disengagement Q&C; related activities.
Key Responsibilities
Onboarding of new External Manufacturers (EM) & NPI
Negotiate action plan with new EM and follow-upon completion
Negotiate the initial Quality Agreement with the new EM
Execute all necessary activities to add new EMs to the Kenvue Approved Supplier List
Be the first point of contact for the regional or global project teams managing the new products
Build relationship with the key stakeholders for the new EMs such as EM Make, Procurement, R&D;, MS&T;, Analytical, R&D; Q&C;, Global Packaging, Regulatory and any other relevant stakeholder




Support all activities related to new product introduction (NPI) such as process validation, cleaning validation, stability, product specifications
Preparation of FG specifications, marketed product stability protocols
Manage the post-launch monitoring including managing quality issues, complaints and change controls
Introduce new EMs to Kenvue Quality Metrics and follow them up
Management of the assigned EMs portfolio against the acceptable GMP and applicable ISO Standards (i.e: Eudralex, FDA 21CFR 210/211, ISO 13485, ISO 22716, ISO 9001, ISO 22000)
Follow-up audit action plan proposal and progress
Management of quality issues: review of deviations, out of specifications, non-conformances and other critical issues; investigation review and follow up on resulting action plans
Ensure continuous improvement process of the External Manufacturers through KPI Management, Action Plan and CAPA follow-up
Collect change control related in

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a76ll