Johnson & Johnson
Compliance Lead
Compliance Lead
Location: Leiden (hybrid working 3 days onsite,2 days remote)
Contract till: Dec 2024
The Role:
As Compliance Lead, you will lead a team of highly qualified engineers/technicians within the EVM department. The compliance supervisor gets the best out of his or her people by taking diversity, inclusion and equity aspects into account and is responsible to deliver high-quality within the complexity and dynamics of a research and development organization.
As MT member you lead the department to develop to the next level and take ownership for the broader organization.
You will work closely with the other EVM team leads and internal partners to maintain/improve the department’s high GMP and EHS standards fulfilling the needs of a safe, high quality and continuously improving R&D organization.
The Team
Engineering-Validation-Maintenance (EVM) Department:
The Engineering-Validation-Maintenance (EVM) department is a motivated and dynamic team responsible for the technical support of all utilities, production and laboratory areas and all involved equipment at the Janssen Vaccines & Prevention site in Leiden.
We work in a challenging environment where we make great progress in developing our advanced therapies. Engineering has a large project portfolio to sustain/improve the existing environment.
The Compliance group looks after the correct qualification and validation status of GMP critical equipment and processes. Furthermore, the compliance group is responsible for the overall quality and safety programs within EVM.
The key-focus point of the maintenance groups (U&B, Automation and Equipment group) is asset maintenance management of all assets within JVP.
The Role:
As Compliance Lead, you will lead a team of highly qualified engineers/technicians within the EVM department. The compliance supervisor gets the best out of his or her people by taking diversity, inclusion and equity aspects into account and is responsible to deliver high-quality within the complexity and dynamics of a research and development organization.
As MT member you lead the department to develop to the next level and take ownership for the broader organization.
You will work closely with the other EVM team leads and internal partners to maintain/improve the department’s high GMP and EHS standards fulfilling the needs of a safe, high quality and continuously improving R&D organization.
Job Description / Responsibilities:
As a people manager, ensuring that there is a stable team with a positive constructive atmosphere. You motivate, coach, and support your employees to get the best out of your team.
Performing people management task e.g., holds the "5 conversations, recruitment and selection, absenteeism guidance, coaching, propagating the CREDO values.
Setting priorities and aligning them with the departments involved, constantly assessing, and improving the efficiency of the quality and safety processes and the team, so that the technical assets and the resources are optimally utilized.
Defining team objectives, translating them into activities and responsibility to achieve the overall results of those activities.
Ensuring the Life cycle management of technical assets is performed in accordance with pharmaceutical regulations, e.g.: GAMP 5, Annex 1.
Ensuring the implementation/maintenance/continuous improvement of all safety aspects of the Johnson & Johnson EHS program within the field of the Engineering and Maintenance processes.
Ensuring ownership of company quality standards and procedures.
Ensuring the implementation/maintenance of systems capable of visualizing departmental performance.
Ensure departmental readiness for internal/external audits on quality and safety.
Improving the department by using PE tools, Project management tools, and departmental goal setting
Ensuring sufficient training (regulatory requirements, process excellence, etc.) and occupation of the team members.
Competences:
Proactive, Sense of urgency
Strategic thinking: setting frameworks and goals and translating the departmental vision from the Business Cascade.
High degree of accuracy, initiative, and independence.
Flexible, can deal with changing priorities and stress resistant.
Enthusiastic Team player, flexible, “Can do” attitude, critical and proactive.
People management skills: supportive leadership, change management skills, motivating and coaching, developing the individual and the team to a higher level.
Diversity & Inclusion: Making optimal use of different talents, knowledge, and skills.
Credo: Applies an example function in your own behavior and stimulates this behavior and attitude.
Collaboration and communication: Build solid, productive relationships inside and outside the department.
Qualifications:
Education: Bachelor’s degree in engineering, biotechnology, automation (or equivalent education).
Specific Knowledge and experience:
Minimal 10 years of experience in biotechnology/pharmaceutical/process industry environment with people management experience.
Proven organizational, managerial capacities and demonstrated flexibility to respond to changes in the external and internal environments.
Knowledge of pharmaceutical manufacturing, current Good Manufacturing Practices (cGMP) and safety regulations.
Validation and qualification aspects of pharmaceutical and/or bio processing equipment, utilities and facilities.
Strong influencing skills with ability to see issues from multiple viewpoints.
Good command of English in word and writing.
Experience with Lean methodology is preferred.
What’s in it for you?
As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected.
At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.
www.janssen.com
Benefits
This role offers a very competitive hourly rate.
about Johnson & Johnson
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
At the Leiden Site, talented and multi-skilled people are working in a high-performing culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Compliance team in Engineering, Validation and Maintenance (EVM) department we are looking for an enthusiastic and dedicated:
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
Diversity, Equity & Inclusion
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 one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”