Senior Quality Engineer - SM API (M/F/X)

Within Janssen Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Senior Quality Engineer SM-API (M/F/X) as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium. Janssen Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-APIs used in treatments that improve the health and lifestyle of people worldwide. Janssen Supply Chain Quality (JSCQ) SM-API supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs guaranteeing reliable supplies in compliance with applicable regulations. As Senior Quality Engineer SM-API, you are responsible for the quality oversight and timely release of an assigned product portfolio of commercial APIs, ensuring compliance with applicable regulations. You will also provide quality support to the production plants. Job Description: Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results. Strengthen the quality culture in the supporting departments by providing coaching and/or training on cGMP requirements. Ensure Quality oversight of commercial APIs manufactured at Janssen’s Supply Chain site in Geel. Work as One team with QA and Supply Chain partners to ensure timely release in support of a reliable supply chain. Ensure that deviations, CAPAs, Change Controls and Product Quality Complaints are timely and properly investigated by providing quality, compliance and technical expertise such that the internal and external customer expectations are met. Ensure that deviations and complaints with potential impact on patient safety and/or product supply are properly handled and escalated. Review and approve Annual Product Review (APR) and Continued Process Verification (CPV) reports for the assigned product portfolio of commercial APIs. Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation. Serve as Subject Matter Expert for assigned Quality Processes. Act as spokesperson during Health Authority inspections and customer audits. With focus on Quality activities, develop and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora. Continuously challenge the status quo by identifying opportunities for continuous improvement. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance. Qualifications Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …). Industrial Pharmacist – EU certified Qualified Person is an asset. Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset. Demonstrated ability to work independently while staying connected with key stakeholders. Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels of the organization are important. Strong analytical thinking skills and able to work in a flexible way under time pressure. Ability to make risk based decision under time pressure. Understands the business implications regarding quality positions and decisions. In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures. Experience with Quality Systems. Experience with regulatory inspections and preparedness. Project management skills is an asset. You speak and write fluent Dutch and English. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Primary Location Belgium-Antwerp-Geel- Organization Janssen Pharmaceutica N.V. (7555) Job Function Engineering Requisition ID 2206075322W