Director Quality Assurance, Geel

Johnson&Johnson Innovative Medicine Supply Chain is recruiting a QA Director– Commercial Drug Product&Qualified Person– to oversee Pharmaceutical Drug Product manufacturing based in Beerse, Belgium. This role will lead a team of QA managers and professionals responsible for the quality oversight and timely release of Drug Products manufactured at the commercial facilities of the Beerse site. The Supply Chain Quality (SCQ) team supports the Beerse site in its mission as a Launch&Grow site and is responsible for the quality oversight and final release of Drug Products guaranteeing reliable supplies in compliance with applicable regulations. Job Description

Lead a team of QA managers and professionals by supporting, coaching, and developing team members in reaching quality, business, and personal objectives. Act as Qualified Person ensuring continuous evaluation of GMP quality systems used in the different manufacturing areas operating under the legal entity of Janssen Pharmaceutica NV, Beerse, and certify each batch of finished commercial product released by Janssen Pharmaceutica, Beerse before being released for commercial use in the EC/EEA or for export.Establish and maintain strong working relationships with Business Partners in Supply Chain as well as local and global 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.Act as QA Point of Contact for commercial Drug Products ensuring timely release in compliance with global regulations and J&J quality requirements. Represent Quality in review meetings governing Quality and Compliance metric and operational business performance of the Quality Unit; identify trends and define actions ensuring continuous improvement of the Quality and Compliance performance at the site. Apply Quality Risk Management tools in order to proactively detect risks and define mitigation plans by risk‑based decision making balancing business implications with Quality and Compliance requirements; ensure that risks with potential impact on patient safety and/or product supply are properly escalated.With focus on Quality activities, provide strategic direction and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora; continuously challenge the status quo by finding opportunities for continuous improvement; drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality, and compliance performance.Review and approve procedures and work instructions. Ensure that quality records such as investigations, CAPAs, Change Controls are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met. Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.Remain current in knowledge and skills towards regulatory and industry trends. Act as spokesperson during Health Authority inspections and customer audits. Job Qualifications

Master Scientific degree (Pharmaceutical sciences, Medicines, Biology or equivalent) EU certified Qualified Person with at least 10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality. Fluent Dutch and English. Ability to provide strategic leadership to meet business objectives in a highly dynamic business environment.Ability to work independently while staying connected with key stakeholders. Proven track record to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels of the organization are important. People leadership skills, experienced team leader for Supply Chain or Quality team.Proven Innovation Leader who enables creative thinking and drives implementation balancing pragmatism within a GMP framework. Strong analytical thinking skills and able to work in a flexible way under time pressure; ability to make risk‑based decisions under time pressure; understands the business implications regarding quality positions and decisions.Ability to quickly assimilate new modalities and technologies, perform risk assessments and develop action plans. In-depth knowledge in GMP (domestic&international), ICH guidelines, policies, standards and procedures. Experience with regulatory inspections and preparedness. Required Skills

Compliance Management Consulting Corrective and Preventive Action (CAPA) Developing Others Fact‑Based Decision Making Give Feedback Good Manufacturing Practices (GMP) Inclusive Leadership ISO 9001 Leadership Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality ValidationRisk Assessments Standard Operating Procedure (SOP) Succession Planning Tactical Thinking Preferred Skills

Compliance Management Consulting Corrective and Preventive Action (CAPA) Developing Others Fact‑Based Decision Making Give Feedback Good Manufacturing Practices (GMP) Inclusive Leadership ISO 9001 Leadership Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality ValidationRisk Assessments Standard Operating Procedure (SOP) Succession Planning Tactical Thinking Salary:€119 200,00 – €204 355,00. Benefits

Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We alsooffer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

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