Job Information
J&J Family of Companies Sr Supervisor Quality Systems and Compliance for GMP Training in South Holland, Netherlands
Sr Supervisor Quality Systems and Compliance for GMP Training - 2406190618W
Description
Johnson & Johnson is currently seeking an
Sr. Supervisor Quality Systems and Compliance for GMP Training (m/f/d)
to join our team located in Leiden, Netherlands.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .
Job summary:
The Sr. Supervisor Quality Systems and Compliance - GMP training is responsible for the management and delivery of GMP training to Janssen Biologics Leiden and is the Leiden (system) owner of Global Quality Systems that are used to manage and document the execution of quality processes in line with the company and regulatory standards and requirements. You work with the Global teams to ensure the fitness-for-use, roll out and performance of these (electronic) Quality Systems. You collaborate with all business unit stakeholders at the site to support them for the GMP training process.
As a supervisor you are also accountable for the personnel on your team, their performance and development.
Janssen Biologics Leiden Operations delivers key commercial Biotherapeutic products (API) like Remicade, Simponi and Stelara, but has also build a strong expertise in Vaccines and Viral vector production and testing activities. Currently the site is also starting the introduction of Gene Therapy Products.
Activities within the Quality Systems & compliance department comprise the full spectrum of Quality Systems within Janssen Biologics Leiden (e.g. GMP training, Doc management, Non-Conformances/CPA, Change control, Validation, Risk management, APR etc) to support all the site manufacturing and testing activities for Biologic and Advanced Therapy products.
The Sr. Supervisor is a member of the Quality Systems & Compliance Management team, and as such plays a major role in providing advice on Quality Systems to all departments, which are part of the Supply chain. The position provides a unique opportunity to work on the latest and future technologies in biopharmaceutical manufacturing, and you will become part of a worldwide network of Quality Systems experts within and beyond Janssen.
In addition, your personal leadership skills will be asked for, and will be further developed, in your continuous shaping and improving of the Quality System function.
Responsibilities & Accountabilities:
Manages, leads & motivates the GMP training team (3-5 persons) to enhance performance and achieve business goals, agreed metrics & budgets
Functions independently to make daily judgments to balance business need, regulatory requirements, continuous improvement and cost efficiency projects related to the GMP training activities and the performance of the electronic Quality Systems. Defines the long term strategy for the GMP training activities for the site in close collaboration with the business unit stakeholders and the global quality systems organization.
Assess impact, risks and make immediate decisions regarding the departmental activities. In case of major quality events in the area of responsibility you are the primary adviser for the Sr manager QS&C and all business stakeholders at the site.
Collaborates frequently with managers, supervisors/team leaders and operational levels across Janssen Biologics. The function requires good communication and influencing skills to ensure proper compliance levels and service to the organization.
Acts as WW contact for the site in the area of responsibility. The person is able to negotiate a favorable solution for all parties involved, even when interests are colliding.
Supports inspection readiness programs and manages the process during Quality Regulatory inspections.
Replaces other Quality system team members, and the Sr manager QS&C when needed.
Qualifications
Required Qualifications and Competences:
Minimum of Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering.
Minimum of 6 years experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company.
Experience in a (project) lead or people supervisory position is preferred
Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations.
Team player, and ready to take a stand when necessary.
Expertise in Computer systems and Innovative technology systems would be a plus.
Good written and oral communication skills in Dutch and/or 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.
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.
We are offering you a diversified position with a variety of responsibilities in a dynamic and complex international environment. If you we have sparked your interest then please send us your complete online application (CV, cover letter) in English.
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization Janssen Biologics (7266)
Job Function Quality Systems
Req ID: 2406190618W