Johnson & Johnson Careers

Q&C Lead *Based anywhere in Europe!*

Zug, Switzerland
Compliance


Job Description

Requisition ID: 1805674743W

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

*We are looking for a dedicated Q&C Lead to be 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 & NPI (EM):
- 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)
- 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 EM to J&J 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 (Source).
- Execute on all activities related to new product introduction (NPI) such as process validation, cleaning validation, preparation of product specifications.
- Manage the post-launch monitoring for an assigned portfolio of new EMs including managing quality issues, complaints and change controls.
- Introduce new EMs to J&J Quality Metrics and follow them up.
- Support Supplier Reliability initiatives at new and existing EMs

- External Manufacturers (EM)
- Manage an assigned portfolio of EMs on an interim or longterm basis against applicable GMP and ISO standards
- EM management involves: management of quality issues including related corrective actions, planning and follow-up on change controls, review stability data, review and approve Product Quality Reviews in case of OTC products
- Assure continuous improvements of the assigned EMs through KPI and CAPA follow-up
- Follow-up of monitoring audit action plans and execute for cause audits in case needed

- 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 J&J standards at a regional and global level .

Qualifications
A Masters Degree is required in Engineering, Pharmacy, Chemistry, Life Science, or related disciplines.
More than 8 years experience in Quality/Manufacturing in the Health Care industry.
Experience in a GMP and/or ISO regulated industry (manufacturing/QA/QC).
Experience in MD would be a benefit.
EU, FDA and ISO regulations knowledge is required.
Ability to work in a matrix organization.


Primary Location
Switzerland-Zug-Zug
Organization
Cilag GmbH International (8525)
Job Function
Compliance
Requisition ID
1805674743W