Quality Manager – NPI

🕒 Junho 29

🌽 Illinois – Remoto

🌽 Illinois – Remote

💵 $86.880 - $97.740 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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PCI Pharma Services

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1971

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A PCI Pharma Services é uma Organização de Desenvolvimento e Manufatura por Contrato (CDMO) líder, especializada no setor farmacêutico. Eles oferecem uma gama de serviços, incluindo entrega avançada de medicamentos e produtos combinados de dispositivos farmacêuticos, serviços de ensaios clínicos e embalagem comercial. Com mais de 20 anos de experiência em desenvolvimento e fabricação estéreis, a PCI Pharma Services foca em fornecer terapias transformadoras através da inovação e do design centrado no paciente. Sua ampla expertise permite gerenciar um portfólio diversificado de terapias biofarmacêuticas e medicamentos personalizados desde o desenvolvimento até a comercialização. A empresa opera globalmente, apoiando seus clientes com instalações GMP na América do Norte, Europa e Ásia-Pacífico.

Descrição

• Lead a team of Quality Professionals responsible for managing Design Control activities for NPI projects and direct cross-functional team members to achieve on-time quality deliverables, pristine customer service, value-add results • Ensures delivery of all quality elements needed to facilitate new product introductions of combination products • Develop Advanced Drug Delivery Product Quality Assurance strategies and implements agreed strategy to support the development of NPI projects • Makes key decisions on product quality, compliance, and regulatory conformance issues for combination products and ensures risk-based escalations to leadership • Working with the programme and project managers manage project timelines to ensure Quality elements of projects are delivered on time and critical paths are identified and monitored throughout their lifecycle • Promote engagement at all levels and stages of the program • Encourage individuals to contribute to the success of each project and illustrate benefits brought about • Manage risks within the program - ensuring risks are identified, evaluated, and controlled through the program lifecycle • Follow and comply with the NPI process as per company procedures and policies • Display strong leadership to the various project teams from concept to handover • Lead by example in day-to-day project and team management • Manage change at varying levels ensuring site procedures are followed and change controls are raised at the appropriate time with the relevant approvers engaged from the outset • Create and sustain a working environment that promotes the PCI Values and Behaviours • Collaborate with Customer to define KPI’s and lead reporting of KPI’s to Site and Customer Teams • Manage and ensure the quality element of all new products/devices and their associated project phases • This position may require overtime and/or weekend work.

🎯 Requisitos

• Bachelor’s degree in engineering, Life Sciences, or related technical discipline • Minimum of 10+ years of progressive experience within pharmaceutical, biotech, or medical device industries • Expert knowledge of GAMP 5, 21 CFR Parts 820, 210/211, and 11, and data integrity regulations • Strong understanding of Product Life Cycle Management, Design Assurance, and Project Management • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs • Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required • Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables • High Standard of Report Writing Ability to effectively present information to various people as the job requires • Ability to identify and resolve problems in a timely manner • Ability to display original thinking and creativity • Ability to show success in managing employees • Ability to demonstrate attention to detail • Ability to set and achieve challenging goals.

🏖️ Benefícios

• paid time off • health insurance coverage (including dental and vision) • flexible spending account • 401(k) plan