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EM Q&C Lead - 2407018473W

Description

Kenvue is currently recruiting for:

Q&C Lead Make Quality EMEA External Manufacturing

This position reports into the Senior Manager Make Quality EMEA External Manufacturing. You will be based in Prague, Czechia.

Who We Are

At Kenvue (https://kenvue.sharepoint.com/teams/PXEB-EB-assets/Shared Documents/2. Final Assets from Corporate Brand Design/kenvue.com/careers) , 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 up with 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 (https://www.youtube.com/watch?v=XhsbOsBiX_M) .

What You Will Do

The Q&C Lead will provide Q&C leadership support in the management, deployment and implementation of Q&C initiatives to assigned contract manufacturing sites (EM) engaged in the production of Kenvue products. You will be responsible for ensuring Quality & Compliance of Kenvue products manufactured by manufacturing plants and marketed in EMEA region.

Responsibilities

• External manufacturers:

o To manage the assigned External Manufacturing portfolio against the acceptable GMP and applicable ISO Standards (i.e: 9001; 13485) as well as the new Medical Device Regulation (MDR) for our medical device and combination products.

o To manage quality issues: review of deviations, out of specifications, non-conformances and other critical issues; investigation review, follow up on resulting action plans.

o To collect change control related information from External Manufacturers (EM), evaluate proposed changes, collect R&D, regulatory and procurement assessments, prepare action plans and follow up, evaluate product documentation, assess validation protocols and reports.

o To review complaints, support of complaint investigation, follow up of EMs action plan resulting from complaint investigations.

o To review Product Quality Reviews, follow up on resulting action plan with the assigned EM(s).

o To review stability data, follow up on action with the assigned EM(s).

o To Support New Product Introductions for your assigned EM portfolio. Represent Quality in the cross functional project teams.

o Build solid partnership with Procurement, External Make, R&D, R&D Q&C, Global Packaging, Regulatory and any other relevant stakeholder.

o To assure continuous improvement process of the External Manufacturers through KPI Management, Action Plan and CAPA follow-up and evaluation of cost improvement opportunities.

o To lead and follow-up on the implementation of the different QA projects/new Standard Procedures at the assigned EM sites.

o To regularly communicate status & results (including escalation)

o Team Coordination: coordinate management of EMs throughout all life cycle management activities including resources evaluation, ensure deployment of best practices. Recruitment, objective setup, follow-up and appraisal. Provide the team with ad-hoc coaching and appropriate training, skills and support necessary to accomplish their tasks.

• EMEA Regional Program:

o To take part in Regulatory & Compliance initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM(s) sites

o To take part in the implementation of the different QA projects / new Kenvue standards or new regulations at a regional and global level

• Support to EMs Business & External Growth:

o QA support for any business continuity or grow projects.

Qualifications

What We Are Looking For

Required Qualifications

• Master Science or equivalent in Pharmacy, Chemistry or related field or equivalent.

• Knowledge of pharmaceutical development, manufacturing, and quality control methods, and quality assurance principles

• Good knowledge of European legislation and guidance on Medicinal, Cosmetic, Medical Device products including GMps and ICH guidelines

• Understanding of regulatory requirements for pharmaceutical product registration

• Minimum 5 years of industry experience in Quality functions/validation in the Pharmaceutical Industry/Medical Device Industry

• Fluent English (spoken and written)

• Project management skills

• Good communication skills

What’s In It For You

• Competitive Benefit Package

• Learning & Development Opportunities

• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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.

Primary Location Europe/Middle East/Africa-Czechia-Prague-Prague

Job Function Quality (Generalist)

Organization : JNTL Consumer Health I (Switzerland) GmbH

Req ID: 2407018473W