Q&c Lead

**Q&C Lead**-2307002895W

Description

**Johnson & Johnson New Planned Consumer Health Company,** based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

**Q&C Lead**, based in
**any of our European sites**

***

**Role Summary**:
Provides Q&C leadership in the onboarding of new External Manufacturers (EM) in the portfolio of EMEA Source Q&C management, including pre-scouting, qualification, new product introduction (NPI) and post-launch monitoring of these EMs as well as the introduction of the new products linked to the new EMs.

**Major 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)
- 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 and Procurement
- 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

**EMEA Regional Program**:

- To take part in Regulatory Compliance initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM sites
- To 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**:
**Job Knowledge Requirements**:

- Bachelor's Degree is required in Engineering, Pharmacy, Chemistry, Life Science, or related disciplines
- At least 6 years experience in a GMP and/or ISO regulated industry (manufacturing/QA/QC)
- EU, FDA and ISO regulations knowledge
- Experience in MD would be a benefit
- Auditing background is preferred
- Strong communication, teamwork and problem-solving skills
- Ability to work in a matrix organization
- Fluent English and a second European language is desirable
- Position includes international travels

Primary Location Europe/Middle East/Africa-Italy-Lazio-Pomezia (Santa Palomba)

Organization Johnson & Johnson S.p.A.

Job Function Compliance