External Manufacturers Quality Assurance Lead
About the role
Kenvue is currently recruiting for a:
External Manufacturers Quality Assurance Lead
What we do
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.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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.
Role reports to:
EM Quality Head EMEA
Location:
Europe/Middle East/Africa, Italy, Lazio, Rome
Work Location:
Hybrid
What you will do
Kenvue is currently recruiting for:
External Manufacturers Quality Assurance Lead
This position reports to External Manufacturers Lifecycle Manager and is based at Norrbroplatsen - Helsinborg, Sweden.
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 information from EMs, evaluate proposed changes, collect technical functions (R&D, MS&T, Analyrical etc. as applicable), regulatory and procurement assessments, prepare action plans and follow up, evaluate product documentation, assess validation protocols and reports
Review complaints, support of complaint investigation, follow up of EMs action plan resulting from complaint investigations
Collect and review of Product Quality Reviews, follow up on resulting action plan with the assigned EMs
Review stability data, follow up on action with the assigned EMs
Lead and follow-up on the implementation of the different QA projects/new Standard Procedures at the assigned EM sites.
Regularly communicate status & results (including escalation)
Be the first point of contact for the regional or global project teams managing the new products
Build relationship with the key stakeholders 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
Monitor EMs via Kenvue Quality Metrics and follow them up
EMEA Regional/ Global Program:
Take part in Regulatory Compliance initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM sites
Take part in or lead implementation of the different QA projects / new Kenvue standards at a regional and global level
Support to EMs Business & External Growth:
QA support in BCP / Reformulation / CIPs
Support in Supplier Reliability initiatives at new and existing EMs as agreed with line manager and Q&C Projects leader
What we are looking for
Required Qualifications
Bachelor's Degree is required in Pharmacy, Chemistry, Life Science, or related disciplines
Good knowledge of European legislation and guidance on Medicinal, Cosmetic, Medical Device, Nutritional products including GMps and ICH guidelines (i.e. Eudralex, FDA 21CFR 210/211, ISO 13485, ISO 22716, ISO 9001, ISO 22000)
At least 5 years experience in a GMP and/or ISO regulated industry (manufacturing/QA/QC/Validation)
Knowledge of pharmaceutical development, manufacturing, quality control and quality assurance principles
Understanding of regulatory requirements for pharmaceutical product registration
Strong communication, teamwork and problem-solving skills
Project management sills
Fluent English
Position includes up to 15% international travels
Desired Qualifications
Experience in MD and/or Nutritional would be a benefit
Auditing background is preferred
Second European language is desirable
What’s in it for you
Competitive Total Rewards Package
Learning & Development Opportunities
Employee Resource Groups
Annual base salary for new hires in this position ranges: 45.560 – 61.640 euros
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Questions about this role
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