EM QA Lead

September 19, 2024

Kenvue

Helsingborg

Description

Kenvue is currently recruiting for:
EM QA Lead
This position reports to Manager, EM Lifecycle Management and is based at Helsinborg, Sweden.
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 OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands like NEUTROGENA®, LISTERINE®, NATUSAN®, PIZ BUIN® and o.b. ®. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.
The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.
The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here

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 new EMs onboarding, 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:
- Be involved in pre-scouting activities and support the decision process for new external partners
- Execute initial GMP audits at selected EMs against the relevant guidelines (Eudralex, FDA 21CFR 210/211, ISO 13485, ISO 22716, ISO 9001, ISO 22000)
- 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)
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

Qualifications

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
Full proficiency in English, both written and verbal.
Position includes up to 25% 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 Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Sweden-Skåne-Helsingborg

Job Function Compliance

We regret to inform you that this job opportunity is no longer available