(Associate) Director AD quality

Janssen Vaccines & Prevention B.V., previously Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases. In the Analytical Development (AD) Department, we are responsible for the development and validation of methods for QC release and stability testing, product and process characterization of our Vaccine products. AD is working on products in early and late clinical phases up to and including Vaccine launch; e.g. our Janssen COVID and Ebola Vaccines. We are looking for an (Associate) Director leading the AD quality group accountable for GMP compliance in AD including release of product intermediates, drug substance (API) and drug products, and GMP training, Change Controls, Quality Issues, internal inspections, and audits. You will report to the Head of AD. We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. Responsibilities and duties You will be leading a group of ~ 15 GMP experts, managing ICH stability studies, reference materials and be accountable for the role of Head of QC as defined in GMP regulations. Next to people development, performance and resources management, and continuous improvement, the role contains the following responsibilities and duties: Approves critical Quality control documents, including but not limited to Technical agreements and Quality agreements with contract labs, Analytical method transfer and analytical method- and analytical equipment- validation protocols and reports, Stability Data trend reports and sample plans. Acts as lead on QCD systems and processes during regulatory inspections and audits. Partners with business colleagues to integrate and operate comprehensive Quality Control systems (i.e. sample management, calibration, assay validation, OOT/OOS investigations) to ensure safe products Provides oversight and mentoring of the quality control system performance, and initiates and implements continuous improvements Ensures proper assessment and escalation of analytical method deviations Active member of the Janssen Vaccines Site Management Quality and specification review board Qualifications You should have a proven track record of 5-10 years in a biopharmaceutical drug development environment with broad experience of leading QC and/or QA departments. Extensive knowledge on the following items are crucial requirements for this role: Current GMP regulations, GMP quality systems, quality management Biopharmaceutical product specifications and testing Vaccine or viral vector experience Method and equipment validation We look for the following skills: Phased appropriate quality and scientific mindset Solution oriented Ability to build strong relations and strategic alignment with key partners Lean and coaching attitude Excellent organizational and communication skills Diversity, equity, and inclusion attitude You have preferably a masters/PhD in Chemistry, Pharmacy, or equivalent life sciences degree and speaks proficient English. Our company offers a broad range of benefits and a competitive salary, as well as flexible hours and home office possibilities. Are you our perfect candidate and ready to take this step in your career? Help us to get these vaccines on the market and be part of this outstanding opportunity! We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Primary Location Netherlands-South Holland-Leiden- Organization Janssen Vaccines & Prevention BV (8852) Job Function R&D Requisition ID 2105996921W