Johnson & Johnson Careers

NPI Manager

Leiden, Netherlands
Quality (Generalist)


Job Description

Requisition ID: 1805679319W

The NPI Manager is responsible for managing and coordinating the NPI activities of the One Lab associates engaged in transferring primary and secondary analytical method and technology transfers to ensure compliance with quality standards

 
Tasks and Responsibilities
 
Technical and job specific

• Ensure NPI projects are in line with the FPX transferring timelines, resources and budget.

• Manages implementation/transfer of test methods, new technologies, training and procedures.

• Ensure NPI team is subject matter expert and has a leading role during the GMP inspections.

• Review and authorize validation documentation related to the NPI test methods.

• Assess/Initiates Change controls related to the NPI projects. 

• Participate in Management meetings; NPI One Lab network community and PDMS

 
Managerial

• Mentors, coaches, trains and develops the quality control staff. Evaluates performance and provides opportunities for growth.

• Manager the budget of the group with regards to planning and allocations

 
 Compliance

 Employee safety and health

• Ensure that procedures and guidelines linked to safety and health are met Environmental care

• Ensure that the group complies with the environmental procedures and guideliness

 
Quality

• Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.

• Ensure that data are generated and maintained according to current regulatory requirement



Qualifications
Education / Qualification 
  • Master degree in chemistry & biotechnology or equivalent by experience with 8-10 years’ experience in the pharmaceutical industry.
 Professional experience 
  •  Experience in Quality Control, Method development, validation, etc.
  •  Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)
  •  General knowledge of pharmaceutical development & manufacturing
  •  Organizational planning and problem solving experience
  •  Strong leadership & development qualities
  •  Experience with principles of Process Excellence, Lean manufacturing, etc.
  •  Good presentation skills
  •  Excellent knowledge of English
 Personal and interpersonal skills 
  •   Analytical thinking
  •   Strong Quality Awareness
  •   Flexible
  •   Stress resistant
  •   Organizational and people management skills
  •   Dealing with intercultural differences
  •   Work independently
 Personal attitude 
  •  Team player
  •  Communicative
  •  Open minded
  •  Listener
  •  Open for change and improvement
  •  Accurate and analytical mindset


Primary Location
Netherlands-South Holland-Leiden
Organization
Janssen Biologics (7266)
Job Function
Quality (Generalist)
Requisition ID
1805679319W