Johnson & Johnson Careers

FPO Compliance & Continuous Improvement specialist

Beerse, Belgium
Quality (Generalist)


Job Description

Requisition ID: 1805678487W

The DPDS Clinical Supply Chain (CSC) is part of the global Janssen R&D organization within Johnson & Johnson and is globally responsible for all clinical supplies for Janssen R & D. Our activities include all internal and external planning, production and distribution of clinical supplies (API, Drug Product, and packaged clinical supplies) via a global network. We deliver to more than 60,000 patients in more than 300 clinical trials every year.

 

The FPO Drug Product Pilot Plant (PP) in Beerse, part of the DPDS-CSC organization has a vacancy for a Senior specialist / Manager Compliance & Continuous Improvement

 
 
Responsibilities:
 

Responsible for coordination of all compliance and continuous improvement activities in FPO.

 
 
Activities:
 
  • Compliance:
    • Coordinate and follow up of timely closure of FPO owned quality records like events, deviations and CAPA’s
    • Timely implementation of own, assigned quality records
    • Coordinate timely assessment and follow up of complaints
    • Point of contact for QA for changes in regulations and SOP’s
    • Prepare, coordinate and support (as spokesperson) internal and external quality audits
    • Creating and maintaining training plans for all FPO employees
    • Responsible for onboarding process for FPO
    • Responsible for all quality improvement efforts in FPO
    • Responsible for metrics in FPO
 
  • Continuous improvement:
    • Ownership of lean transformation roadmap for FPO
    • Translate lean transformation roadmap into specific projects
    • Identify key areas for improvement and provide leadership in deploying the lean activities.
    • Manage IFO (Idea for Improvement) and 5S programs in FPO
    • Promote a culture of continuous improvement in the organization


Qualifications
  • Master in engineering, Pharmacy, Bio-sciences or equivalent by experience
  • Very strong Quality/Compliance focus
  • Hands-on type manager
  • Continuous improvement mindset
  • Strong relationship builder (CSC, QA, DPD,…) and excellent in stakeholder management
  • Detail oriented
  • Excellent communication skills
  • Cultural influencing skills
  • Training skills
  • Fluent in English and Dutch or willing to learn

Primary Location
Belgium-Antwerp-Beerse
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality (Generalist)
Requisition ID
1805678487W