Johnson & Johnson Careers

Sr Manager QA NPD

Leiden, Netherlands
Quality Assurance


Job Description

Requisition ID: 1905726512W

The (Sr.) Manager QA New Product Development (NPD) & Launch is responsible for making sure that the JBV quality systems are applied as per GMP standards within Janssen Biologics. Quality NPD & Launch is a newly setup department that supports the manufacturing of New Products and Launch processes. One key aspect is to increase the NPD & Launch speed of new products. For this close collaboration with Biotherapeutics Development and the Vaccines Launch Facility is required.

 

Activities within the department comprise the full spectrum of Quality processes (e.g. Batch Record Review, Product Release, Changes, NonConformances, CAPAs and complaint handling, Process and Cleaning validation, etc).

 

The (Sr.) Manager is a member of the Quality Management team, and as such plays a major role in providing advice on Quality topics to all departments, which are part of the Supply chain. The position provides a unique opportunity to work on the latest and future technologies in biopharmaceutical manufacturing, and you will become part of a worldwide network of QA experts within and beyond Janssen. In addition, your personal leadership skills will be asked for, and will be further developed, in your continuous shaping and improving of the QA function.

 

We are looking for a (Sr) Manager QA NPD & Launch that:

  • Manages, leads & motivates the QA NPD & Launch department and its people to enhance performance and achieve business goals, agreed metrics & budgets
  • Manages and improves (leading to acceleration of) the GMP processes to facilitate the production of New Products in both the JBV BTD Pilot plant and the Vaccines Launch Facility
  • Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
  • Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the site’s quality systems, projects and programs to maintain GMP compliance, with special focus on NPD & Launch products
  • Supports or leads (global) escalations of issues, which have (potential) impact on the delivery of our NPD & Launch products
  • Replaces other QA MT members, and the SQH when needed
  • Participates in NPI (New Product Introduction), quality and capacity projects, and acts as SME on Quality topics
  • Supports inspection readiness programs and manages the process during Quality Regulatory inspections
 


Qualifications
Required Qualifications and Competences:
  • University degree at a master level in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering
  • Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations
  • 10 years’ experience in Quality of which 7 years is in a managerial, people leading role
  • Knowledge of/and experience in process development
  • Qualification as QP (or eligible to) would be a big plus
  • Perfect written and oral communication skills in Dutch and English
  • Team player, and ready to take a stand when necessary
 
More information:

Starting date: 01APR19

Pay Grade: 30/31 (depending on experience)


 
Are you interested?
Please apply online via Mycareeropportunities (MCO

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Quality Assurance
Requisition ID
1905726512W