Job Information
J&J Family of Companies ATQ Platform QC Manager in Trenton, New Jersey
ATQ Platform QC Manager - 2406182257W
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 (https://www.jnj.com/credo/)
Advanced Therapies Quality Platform QC Manager (m/f/d)
Possible locations: Netherlands, Belgium, Ireland, Switzerland, United States
Job summary
Johnson and Johnson Innovative Medicines, is recruiting for Advanced Therapies Quality Platform QC Manager.
At Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Johnson and Johnson. We collaborate with the world for the health of everyone in it.
This role will have significant impact on patients who are awaiting our Innovative medicines. Enabling release of important medicines to patients in need will make this job very exciting! We are testing innovative medicines at internal and external laboratories. Your experience with Digital systems, data management and data automation will be crucial for our success. You will play a meaningful role in management of testing, to enable product release. We use sophisticated data management systems, automation, and we are supervising testing processes with different data management tools. Establishment and maintenance of the tools we use, will be essential to support the release of our products.
Responsibilities & Accountabilities
Development of global strategy for Data management for cell and gene therapy products, to ensure maximum visibility on business processes.
Effect processes for implementation of testing excellence, metrics and resources.
Act as a link between Data Science and Advanced Therapies operations and quality control to efficiently develop relevant solutions and insights in data.
Applies effective planning and reporting tools to enable risk-based and data-driven decisions by crafting simple visuals of complex processes.
Coordinates data and analytics and develops innovative and agile data management solutions.
Proactively Leads multi-disciplinary projects with different departments, including Quality Assurance, Site QC teams, Global planning, SAP SMEs and external companies where required.
Management and coordination of testing processes at internal and external laboratories.
Collaborates with functional departments to support issues, investigations and resolutions.
Act as eLIMS expert and provide support in data flows, as well as in CoA creation.
Apply Quality Systems: Event and CAPA Management System, Document Management System, Learning Management System, Change Control System and new technologies.
Optimizes testing schedules for laboratories according to manufacturing demand and available test capacity.
Qualifications
Education:
- Bachelor’s degree or equivalent is required, Master degree or PhD in an appropriate field is preferred.
Experience and Skills:
8-10 years of related work experience will enable successful performance.
Experience in a pharmaceutical environment and knowledge of GMP.
Analytical knowledge including knowledge about internal as well as external laboratory operations.
Sophisticated knowledge about Digitalization, Automation and Data science are of significant importance. Automation of testing processes is an important goal for Johnson and Johnson, Innovative medicines.
Leadership skills to lead and train teams to establish and enroll global solutions for data management and automation.
Experience with laboratory management systems and laboratory quality systems.
Expert in Management Review tools, Key performance indicators and Dashboards.
Experience with project management and governance structures.
Strong communication skills
Able to work independently.
Flexible and accurate
Professional proficiency in English
Preferred:
Experience with Cell and Gene therapy product testing.
Experience with External Test Laboratory management.
Process Excellence and lean tools.
Other:
- Travel percentage will be up to 20%.
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.
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.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Other Locations Europe/Middle East/Africa-Switzerland, NA-United States, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Ireland
Organization Janssen Biologics (7266)
Job Function Quality Control
Req ID: 2406182257W