R&D Quality Specialist GMP

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Sweden are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

About McNeil AB – Johnson & Johnson Consumer Health
At Johnson & Johnson Consumer Nordic, we have a truly unrivalled brand portfolio, with power brands across multiple categories, including Neutrogena, Natusan, Piz Buin, o.b, Imodium, Ipren, Livostin and Nicorette. In Helsingborg we manufacture Nicorette and Rhinocort products for the global market. Our Nicorette products - found in over 80 countries - help people around the world to quit tobacco and live healthier lives. In addition to manufacturing, we also have a global research and development unit working in three areas: Smoking Cessation, Digestive Health and Cough & Cold. With around 650 employees we are one of the region's largest companies. Products manufactured in Helsingborg are mostly over-the-counter pharmaceuticals and are produced, tested and released according to good manufacturing practices (GMP).

Introduction and Overview
R&D Q&C is part of the Regional Franchise Quality Self Care organization which is composed of 10 people in the region. The purpose and scope of this team is to ensure quality and compliance, that the application of GxP and Johnson & Johnson requirements to the products being developed, manufactured and used in clinical trials, is effective, safe and have the right quality to ensure that consumers and patients are not exposed to risk using these products.

R&D Quality Specialist GMP
New product development projects support in the Self Care Franchise spanning over product classifications of OTC (over-the-counter), Herbals, Medical Device/Combination product classification and Food Supplement. The activities span from early development and clinical trials to scale up and technical transfer activities. The Specialist GMP are responsible for
developing and maintaining quality systems and controls related to cGxP regulations and Johnson & Johnson policies and standards including development and implementation of new or revised procedures.
product development efforts by providing compliance guidance, participate as compliance representative, review and approve documentation related to projects and compliance, release of supplies to R&D studies, review and approve supplier management related documentation, etc.
validation and qualification activities of lab computer systems.
performing quality activity for Medical Device projects.

Qualifications - External
Bachelor’s degree is the minimum level with a degree in Chemistry, Pharmacy, Technical Engineering or equivalent in related subjects (required)
Experience in Pharmaceutical and/or Medical Device environment (required) from R&D environment (preferred)
Good language skills in local language and English both written and spoken (required)
The work environment is global and requires good networking and collaboration skills (required)
Experience from computerized system validation (merit)
Experience from quality system in relation to software development, especially App development with MD classification (merit)


What you will need to succeed
We are looking for a person who:
can lead his/her own work
masters collaborating with partners in an agile development environment
can understand the holistic view and at the same time is able to focus on details
is a standout colleague
solution oriented
has both technical and social competence.


What type of mark will YOU make?
By joining Johnson & Johnson you will find unlimited opportunities to build your path & amplify your impact inside & outside our walls. Our dedication to be the world’s healthiest workforce provides a range of opportunities to strengthen your body as well as your mind. When you work with us you can touch over a Billion lives worldwide every day, and when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together and that changes everything.

Application
If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the standard 30-days posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
If you have issues applying, please use Chrome Web Browser and reset your password. If that does not help you can get more guidance and contact us from this page: https://www.careers.jnj.com/contactus-faq.