Johnson & Johnson Careers

Delegate QP Vaccines

Beerse, Belgium
Quality Assurance


Job Description

Requisition ID: 1700213886W

• Serves as the Quality Point of Contact and Delegate IMP QP for Vaccines. 
• Acts as IMP QP representative for new Vaccine Introductions, including, but not limited to, timely availability of Quality Agreements. 
• Serves as champion for IMP QP requirements during development of new vaccine products, including fit-for-purpose strategies on GMP requirements. Applies Quality Risk Management tools in support of smart development. 
• Ensures Quality and Compliance operational targets are met. 
• Reviews and approves related GMP documents such as procedures and work instructions, investigations, etc. 
• Supports and acts as spokesperson during Health Authority inspections and customer audits. 
• Remains current in knowledge, skills and industry trends. 
• With focus on Quality activities, develops and fosters an environment of innovative thinking through e.g. benchmarking, training, participation in industry forums. 
• Reports Quality trends and makes a positive contribution by making suggestions for improvement. 

Qualifications
• University degree, scientific orientation (pharmaceutical, chemical or biological sciences). Industrial Pharmacist (Qualified Person) is a must. 
• At least 5 years experience in pharmaceutical industry. 
• Mobility is important, since regular presence at the Leiden facility is expected. • Demonstrated ability to work independently while staying connected with key stakeholders. 
• Experience in Large Molecule development and production, more specifically with vaccines. 
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans. • In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures. 
• Experience with Quality Systems. 
• Experience with regulatory inspections and preparedness. 
• Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels are important. 
• Understands the business implications regarding quality positions and decisions.

Primary Location
Belgium-Antwerp-Beerse
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality Assurance
Requisition ID
1700213886W