Senior Manager QA, Fill & Finishing, Engineering & Operations

ph3Summary /h3 pThe Senior manager will be responsible for Quality Assurance oversight of Engineering and Operations fill finishing related activities at Incyte's manufacturing facility in Yverdon-les-Bains, Switzerland. /p pThe Senior manager will ensure QA deliverables related to classified rooms and utilities qualification, filling line validation, and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements, including Eudralex GMP Annex 1. /p pThe Senior manager will work closely with production, engineering, and manufacturing science teams, ensuring compliance and operational excellence. /p h3Duties And Responsibilities /h3 h3Project phase – Design, Qualification Commissioning /h3 ul liAct as the QA lead in engineering projects involving aseptic filling line, isolator and cleanroom infrastructure. /li liEnsure early QA involvement in design and risk assessments, embedding GMP, Annex 1 and data integrity principles into system architecture and process flow. /li liOversee and approve qualification activities (FAT/SAT, IOPQ), ensuring quality requirements are met prior to operational release. /li liLead the QA assessments of change controls and ensure traceability from design to execution. /li liDrive quality risk management throughout the project lifecycle supporting a right first-time approach in commissioning and validation. /li liSupport the development and approval of GMP documentation, including SOPs, master batch records and protocol required for the new process or equipment. /li liEnsure Annex 1 alignment by integrating contamination control principles, Contamination Control Strategy elements and aseptic process simulation requirements into project deliverables. /li liRepresent the QA function in project meetings to ensure alignment with technical and regulatory expectations. /li /ul h3Operational phase – Aseptic Manufacturing Operations /h3 ul liLead the QA activities related to aseptic filling ensuring compliance with Annex 1 and GMP requirements. /li liEnsure timely review and approval of SOPs, deviations, CAPAs, change controls and batch records, maintaining product release timelines and quality standards. /li liBe the primary QA contact during regulatory inspections and internal audits, demonstrating mastery of aseptic quality systems and facility knowledge. /li liLead by example in cleanroom environment and distill an aseptic manufacturing mindset, ensuring operators maintain the highest standards of sterility assurance. /li liAnalyse Quality KPIs, lead continuous improvement initiatives and elevate quality trends to management. /li liSupport inspection readiness activities and represent QA function for engineering and manufacturing related matters in Health Authorities inspections. /li liCollaborate with cross-functional teams, including production, engineering, and manufacturing sciences, to drive quality and operational excellence. /li liEnsure appropriate risk escalation to QA leadership and QP. /li liPromote a culture of compliance and continuous improvement throughout the project lifecycle. /li liEnsure all activities comply with safety requirements, company policies, and applicable regulations. /li /ul h3Requirements /h3 ul liDemonstrated experience in qualification, validation and GMP operations. /li liMore than 10 years of experience in aseptic process activities, experience in isolator technology is an asset. /li liMore than 10 years of experience in Quality Assurance oversight of pharmaceutical manufacturing projects. /li liAcademic degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering, or related field). /li liStrong knowledge of cGMP and international regulatory requirements for facility qualification and process validation. /li liStrong knowledge of Eudralex GMP Annex 1 and Sterility Assurance concepts. /li liStrong analytical and problem‑solving skills. /li liExcellent verbal and written communication skills with a structured approach. /li liFluent in French (written and spoken); proficiency in English is an asset. /li liAbility to work independently and collaborate with multidisciplinary teams. /li /ul h3DELEGATION /h3 pThe aforementioned activities can be delegated to the QA Manager Tech. Transfer, to the QA Manager Operations and Engineering and to the QA Associate Directors. /p h3Disclaimer /h3 pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p /p #J-18808-Ljbffr