ai software engineer (re2) [470_24_cs_hpai_re2]context and missionthe mission of..

Micropole; Comunidad Valenciana; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

Ein etabliertes Unternehmen in der Pharmaindustrie sucht einen erfahrenen Senior Project Manager, der die Planung und Ausführung komplexer Projekte leitet. In dieser Schlüsselrolle sind Sie verantwortlich für die Einhaltung von GxP-Vorgaben und die Integration von IT-Lösungen. Sie arbeiten eng mit verschiedenen Stakeholdern zusammen, um sicherzustellen, dass alle Projekte erfolgreich und fristgerecht abgeschlossen werden. Diese Position bietet die Möglichkeit, Ihre Führungskompetenzen und Ihr Fachwissen in einem dynamischen Umfeld einzusetzen, während Sie zur Verbesserung der Prozesse und der Einhaltung von Vorschriften beitragen. Wenn Sie eine Leidenschaft für die Pharmaindustrie haben und in einem innovativen Team arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Formación

• Mindestens 8 Jahre Erfahrung im Projektmanagement in der Pharmaindustrie.
• Erfahrung in der Leitung großer, funktionsübergreifender IT-Initiativen.

Responsabilidades

• Leitung und Verwaltung mehrerer hochpriorisierter Projekte im pharmazeutischen Umfeld.
• Sicherstellung der Einhaltung von GxP, FDA und anderen regulatorischen Anforderungen.

Conocimientos

Projektmanagement

GxP Compliance

Stakeholder Management

Risikomanagement

IT-Systemintegration

Agile Methoden

Kommunikationsfähigkeiten

Educación

Bachelor in Pharmazeutischen Wissenschaften

PMP oder PMI-ACP Zertifizierung

Herramientas

MS Project

Jira

Asana

MS Office Suite

Descripción del empleo

We are seeking a Senior Project Manager with extensive experience in the pharmaceutical industry, specifically in managing projects that involve Good Manufacturing Practices (GxP) compliance and IT systems. The ideal candidate will have a proven track record of leading cross-functional teams, driving the delivery of complex projects within the pharmaceutical and life sciences sector, and ensuring compliance with industry regulations. This role is integral to the planning, execution, and management of key projects within a regulated environment, with a focus on integrating IT solutions in support of GxP processes.

Key Responsibilities :

• Project Planning & Execution : Lead and manage multiple high-priority projects, ensuring adherence to project timelines, scope, budget, and quality standards. Coordinate project resources and deliverables to meet business objectives.
• Regulatory & GxP Compliance : Ensure all projects are delivered in strict accordance with GxP, FDA, and other applicable regulatory requirements. Oversee the implementation of IT systems and solutions within the pharmaceutical environment, ensuring that they meet industry standards.
• Stakeholder Management : Collaborate with internal and external stakeholders, including business leaders, regulatory bodies, and IT teams. Maintain clear communication to manage expectations, mitigate risks, and resolve issues as they arise.
• Risk Management : Proactively identify and address risks associated with project delivery, including those related to regulatory compliance, resource allocation, and IT systems integration. Develop and implement mitigation strategies.
• IT System Integration : Manage the end-to-end lifecycle of IT-related projects, from requirement gathering to system design, implementation, and post-deployment support. Ensure that IT solutions are aligned with GxP and other regulatory guidelines.
• Team Leadership & Development : Lead cross-functional teams, including project managers, IT professionals, regulatory experts, and business analysts. Provide mentorship and guidance to junior project managers and team members.
• Continuous Improvement : Drive process improvements within the project management function, adopting best practices and methodologies (e.g., Agile, Waterfall) to increase efficiency, effectiveness, and compliance in project delivery.

Qualifications :

• Education : Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Computer Science, Engineering, or related field. PMP, PMI-ACP, or similar certifications are a plus.
• Experience : Minimum 8+ years of project management experience in the pharmaceutical industry with direct experience in managing IT projects that involve GxP compliance. Proven experience in leading large-scale, cross-functional IT initiatives in regulated environments (e.g., pharmaceutical manufacturing, clinical trials, or laboratory environments). Strong knowledge and understanding of GxP guidelines, FDA regulations, and the impact on pharmaceutical IT systems. Experience with pharmaceutical IT infrastructure, including but not limited to LIMS, ERP, MES, and validated systems.
• Skills & Competencies : Strong leadership and team management skills. Excellent communication and stakeholder management abilities. Ability to navigate complex regulatory environments. Strong problem-solving and risk management skills. Proficiency in project management software (e.g., MS Project, Jira, Asana) and MS Office Suite. Ability to prioritize and manage multiple projects simultaneously.

Preferred Qualifications :

• Experience with ERP, LIMS, or other pharmaceutical IT systems.
• Expertise in Agile methodologies and project management techniques.
• Advanced degree in Life Sciences or related field.

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