Johnson & Johnson Careers

Director IMP QP & Vaccine QP

Beerse, Antwerp
Quality Assurance


Job Description

Requisition ID: 1805656089W

  • Acts as Qualified Person for Investigational Medicinal Products
  • Serves as the Global Quality Point of Contact for IMP QP related topics on Small and Large molecule compounds as well as Vaccines
  • Leads and mentors team of delegate IMP QPs
  • Has QP oversight for the Clinical Phase 1 Unit (CPU) at Merksem
  • Serves as the Single Point of Contact for global Quality departments such as BRQC, PQM, CLS, ESIQ as well as global business partners such as PDMS, VPAD, GCDO and CPU Merksem. Establishes and develops strong working relationships with those departments, including single quality voice regarding IMP QP related topics
  • Serves as champion for IMP QP requirements during development of new products, including fit-for-purpose strategy 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
  • Leads and acts as spokesperson during Health Authority inspections and customer audits
  • Remains current in knowledge, skills and industry trends
  • With focus on Quality activities, develop and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry forums
  • Reports Quality trends and makes a positive contribution by making suggestions for improvement. Ensures defined Quality and Compliance improvements are implemented globally

Qualifications
  • University degree, scientific orientation (pharmaceutical, chemical or biological sciences). Industrial Pharmacist (Qualified Person) is a must.
  • At least 15 years’ experience in pharmaceutical industry
  • Ability to provide strategic leadership to meet business objectives and a highly dynamic business environment
  • Production related expertise required
  • Experience in product development
  • 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
  • People management skills, experienced team leader
  • 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
1805656089W