Manager Quality Assurance Technical Team

Job Description:

Description

"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. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

Manager Quality Assurance Technical Team (m/f/d)
Location: Leiden, Netherlands

Job summary
The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, cardiovascular and metabolism, and pulmonary hypertension.
The Drug Substance Development department in Leiden focuses on advanced therapies, a novel class of medical products that uses cell and gene therapies which have the potential to cure diseases where no treatment is currently available. It's a very exciting field, as no established manufacturing platforms exist for these products. That means that new processes need to be developed to ensure high-quality and efficient production of GMP material!
The Technical QA team is part of Quality Assurance department at Janssen Vaccines & Prevention in Leiden which is transitioning to support advanced therapies. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. The work of QA to shape and deliver the right quality is key for the success of Janssen V&P. You will ensure that the foundation is in place on which new products will be developed! The group is forward looking, working on improving processes, being customer focused and supports the need for speed.
We are recruiting a Manager Technical QA to join our QA team. We are seeking a highly motivated and independent individual who will be overseeing all aspects of the qualification and validation of equipment, utilities, and environmental conditions in our pilot plant and QC laboratories.

Responsibilities & Accountabilities
* Perform QA oversight over equipment qualification, clean water and clean air systems and the associated clean rooms which are used for GMP biotechnological manufacturing.
* Support the management of quality incidents, corrective and preventive actions, and change controls.
* Represents Quality on cross-functional teams and participates in site initiatives and projects.
* Applies quality, scientific and engineering principles for problem solving and advise to the teams.

Qualifications

Qualification
Education:
* BSc or equivalent experience with 2-5 years or MSc or equivalent experience with 0-2 years of Pharma/biotech industry experience.

Experience and Skills:
* Good understanding of regulatory requirements and industry best practices for equipment qualification, clean rooms and clean water systems
* Understanding of GMP data integrity requirements
* Strong connecting and teamwork skills
* Strong communication skills in English

What we offer
Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.
We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Working at Johnson & Johnson
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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are