project manager in pharmaceutical quality

NDA; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

NDA ищет менеджера проектов для координации межфункциональных инициатив в регулируемой среде. Вы будете устанавливать рамки проекта, цели и критерии успеха, разрабатывать планы, управлять зависимостями и рисками, обеспечивая надлежащий уровень качества и соответствие требованиям.

Кандидат должен уметь вести коммуникации на уровне руководства, фасилитировать встречи и обеспечивать выполнение действий до завершения проекта.

Qualifications

• Опыт управления проектами, желательно в фармацевтике/биотехнологиях.
• Опыт координации межфункциональных проектов в матричной организации.
• Понимание систем качества и регуляторных требований.
• Умение планировать и контролировать сроки, зависимости и риск
• Умение вести доклады и управлять ожиданиями стейкхолдеров.

Responsibilities

• Определение масштаба проекта, целей, deliverables и критериев успеха.
• Разработка и поддержка планов проекта, графиков и вех.
• Координация команд и управление зависимостями, ресурсами, приоритетами.
• Управление рисками поставщиков, надзор за качеством, соответствие требованиям.
• Подготовка обновлений по проекту для руководств и регламентных форумов.

Skills

Управление проектами

Коммуникации/Stakeholdermgmt

Фасилитация встреч

Управление рисками

Стратегическое планирование

Обеспечение качества

Работа в регламентированной среде

Tools

Microsoft Project

Job description

Задачи:

Define project scope, objectives, deliverables, and success criteria; develop and maintain project plans, timelines, and milestones; manage dependencies, resources, and priorities Coordinate multidisciplinary project teams and align stakeholders on objectives, responsibilities, and expected outcomes Support supplier and vendor risk management, quality oversight, compliance, quality issue resolution, and escalations Lead project activities that strengthen inspection readiness, address inspection commitments, and support pharmaceutical quality compliance Identify, assess, and communicate risks, issues, and potential delays; develop mitigation strategies, contingency plans, and corrective actions with stakeholders Prepare project updates, recommendations, and documentation for governance forums; document decisions and follow actions through to completion Communicate progress, risks, decisions, and outstanding actions clearly and promptly to project teams, senior stakeholders, and business functions Facilitate project meetings and workshops, encourage constructive discussion, resolve competing priorities, and drive collaborative decision-making Maintain project documentation, schedules, risk registers, and status reports; use project management tools to track progress, resources, dependencies, and delivery performance Identify improvements to project delivery, supplier oversight, and quality management processes, promoting efficient practices and sustainable compliance

Требования:

Demonstrable project management experience, ideally in pharmaceutical, biotechnology, life sciences, or another regulated environment Experience coordinating cross-functional projects in a matrix organisation and influencing stakeholders without direct line-management responsibility Understanding of pharmaceutical quality systems, supplier or vendor oversight, risk management, and regulatory compliance Strong project planning and scheduling skills, including managing milestones, dependencies, resources, risks, and deliverables Proficiency in Microsoft Project and developing detailed project plans and monitoring delivery against agreed timelines Excellent communication, facilitation, and stakeholder management skills; able to lead discussions, manage competing priorities, and elevate issues appropriately Strong analytical and problem-solving skills with a practical, solution-oriented approach High attention to detail, strong organisational skills, and ability to manage multiple activities simultaneously Collaborative working style, accountability, urgency, and commitment to quality and compliance Proactive and results-driven, with ownership of project activities and drive to deliver Comfortable working in a complex, cross-functional environment with multiple stakeholders and competing demands Confident identifying risks, constructively challenging assumptions, and recommending practical solutions Adaptable and organised, able to respond effectively to changing priorities Committed to high standards of quality, compliance, and continuous improvement Будет плюсом: Experience supporting inspection readiness initiatives, audit preparation, regulatory commitments, or quality improvement projects

Условия:

Contract position