PpJohnson 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. /ppThe 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. /ph3Job Description /h3ulliLead a team of QA managers and professionals by supporting, coaching, and developing team members in reaching quality, business, and personal objectives. /liliAct 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. /liliEstablish 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. /liliStrengthen the Quality Culture in the supporting departments by providing coaching and/or training on cGMP requirements. /liliAct as QA Point of Contact for commercial Drug Products ensuring timely release in compliance with global regulations and JJ quality requirements. /liliRepresent 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. /liliApply 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. /liliWith 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. /liliReview and approve procedures and work instructions. /liliEnsure 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. /liliEnsure that deviations with potential impact on patient safety and/or product supply are properly escalated. /liliRemain current in knowledge and skills towards regulatory and industry trends. /liliAct as spokesperson during Health Authority inspections and customer audits. /li /ulh3Job Qualifications /h3ulliMaster Scientific degree (Pharmaceutical sciences, Medicines, Biology or equivalent) /liliEU certified Qualified Person with at least 10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality. /liliFluent Dutch and English. /liliAbility to provide strategic leadership to meet business objectives in a highly dynamic business environment. /liliAbility to work independently while staying connected with key stakeholders. /liliProven track record to work across organizational boundaries through influencing, negotiation and partnering. /liliNegotiation, communication and presentation skills across all levels of the organization are important. /liliPeople leadership skills, experienced team leader for Supply Chain or Quality team. /liliProven Innovation Leader who enables creative thinking and drives implementation balancing pragmatism within a GMP framework. /liliStrong 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. /liliAbility to quickly assimilate new modalities and technologies, perform risk assessments and develop action plans. /liliIn-depth knowledge in GMP (domestic international), ICH guidelines, policies, standards and procedures. /liliExperience with regulatory inspections and preparedness. /li /ulh3Required Skills /h3ulliCompliance Management /liliConsulting /liliCorrective and Preventive Action (CAPA) /liliDeveloping Others /liliFact‑Based Decision Making /liliGive Feedback /liliGood Manufacturing Practices (GMP) /liliInclusive Leadership /liliISO 9001 /liliLeadership /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliSuccession Planning /liliTactical Thinking /li /ulh3Preferred Skills /h3ulliCompliance Management /liliConsulting /liliCorrective and Preventive Action (CAPA) /liliDeveloping Others /liliFact‑Based Decision Making /liliGive Feedback /liliGood Manufacturing Practices (GMP) /liliInclusive Leadership /liliISO 9001 /liliLeadership /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliSuccession Planning /liliTactical Thinking /li /ulpSalary: €119 200,00 – €204 355,00. /ph3Benefits /h3pBenefits: 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 also offer 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. /p /p #J-18808-Ljbffr