Johnson & Johnson Careers
Manager QA-CSC Laboratories
Requisition ID: 1905743538W
‘Caring for the world, one person at a time’… inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products, and services to advance the health and well-being of people.
The Janssen Beerse site serves as Centre of Excellence for the Small Molecule Pharmaceutical Development (SMPD) organization. Laboratories of Analytical Development and Drug Product Development support these research and development activities daily.
Manager QA-CSC Laboratory reporting into the QA-CSC Laboratory group, responsible for quality oversight and support of SMPD and their contract laboratories.
- Serves as Quality point of contact for SMPD Analytical Development and Drug Product Development and their contract laboratories
- Acts as Quality Subject Matter Expert (SME) for Data Analytics, IT projects/applications and assigned analytical techniques to support projects ensuring an appropriate quality and compliance level by applying risk management in line with the intended use and phase of development.
- Remains current in knowledge, skills and industry trends in the analytical development area to ensure fast and compliant on-boarding of new techniques/technologies and support of high-end techniques/technologies and applications e.g. NMR, Spectrometry and Automation, etc.
- Establishes and develops cooperative working relationships within and across SMPD and the global quality organization, including single quality voice in the analytical area
- Reviews and approves laboratory related documents such as validation/transfer/investigation protocols and reports
- Handles quality issues, CAPAs, and Change Controls related to the SMPD laboratories as well as their contract laboratories
- Ensures that Quality and Compliance operational targets are met
- Reviews and approves procedures and work instructions
- Supports quality oversight via periodic quality reviews e.g. internal audits, quality metrics. This includes improving the quality culture to positively influence Quality KPI.
- Reports Quality trends and makes a positive contribution via ideas for improvement
- Supports and acts as spokesperson during Health Authority inspections and customer audits
- Travels occasionally for training or business purposes
- Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences)
- 8-10 years’ experience in pharmaceutical industry
- Experience and affinity with the laboratory environment (method development method validation, release & stability testing, micro,…), quality assurance, pharmaceutical development, instrument qualification, IT, automation
- Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment
- Ability to quickly assimilate new technologies and techniques, perform risk assessments, and develop action plans
- Positively react to changes and show agile behavior e.g. dealing with different quality systems applied by service providers
- In-depth knowledge of cGMP and ICH guidelines
- Project Management skills (e.g. FPX)
- Experience with Quality Systems (e.g. Trackwise, Document management systems)
- Experience with regulatory inspections and preparedness is an asset
- Capable of working under time pressure
- Excellent verbal and written communication skills (Dutch & English)
- Demonstrates Credo and Diversity & Inclusion behavior
- Team player
Janssen Pharmaceutica N.V. (7555)