Compliance Assoc Manager EVM

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

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Job Description:

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

At the Leiden Site, dedicated 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 strengthen our Compliance team in Engineering, Validation and Maintenance (EVM) department we are looking for an enthusiastic and dedicated:

Sr Compliance Supervisor (M/F/D)

Would you like to be directly involved in the fight against major global diseases?

Then keep reading!

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 an ambitious 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.

Job Description:

You lead a team of highly qualified engineers/technicians within the EVM department. The compliance supervisor improves their team's potential by demonstrating outstanding leadership skills and is responsible for delivering 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 leaders and internal partners to maintain/improve the department’s high GMP and EHS standards fulfilling the needs of safe, high quality and continuously improving R&D organization.

You will be responsible for: 

• As a people manager, ensuring that there is a stable team with a positive constructive atmosphere. You empower, coach, and support your employees to get the best out of your team.
• Performing people management task e.g., holding performance/development 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 effectively used.
• 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 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 the occupation of the team members.

Competences:

• Strategic thinking: setting frameworks and goals and translating the departmental vision from the Business Cascade.
• High degree of accuracy, initiative, and independence.
• Flexible, can take care of changing priorities and stress resistant.
• Enthusiastic Teammate, 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.
• Inclusion: be a role model of fair treatment and full participation of all people.
• Credo: applies an example function in your own behavior and stimulates this behavior and attitude.
• Collaboration and communication: build productive relationships inside and outside the department.

Qualifications:

Education: Bachelor’s degree or equivalent in engineering or (bio)process engineering

Specific Knowledge and experience:

• Demonstrated ability 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.