Senior Project Manager Quality Applications (DMS, Cornerstone, Kneat, trackwise) remote!

Fusion Consulting; Barcelona; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A consulting firm specializing in quality management is seeking a Senior Project Manager for Quality Applications in Barcelona. You will lead the implementation and management of quality management systems within a pharmaceutical organization. The ideal candidate has 8+ years of experience in project management and knowledge of GxP regulations and FDA guidelines.

Formación

• Minimum of 8 years of project management experience in the pharmaceutical industry.
• Proven track record of implementing quality management systems.
• In-depth knowledge of GxP regulations, FDA guidelines, and EMA standards.

Responsabilidades

• Develop and execute project plans for the implementation of quality management applications.
• Collaborate with teams to ensure alignment of quality systems with business objectives.
• Manage project timelines, resources, and budgets.

Conocimientos

Project management

Risk management

Interpersonal skills

Analytical skills

Problem-solving

Fluency in English

Educación

Bachelor’s degree in Computer Science, Engineering, Life Sciences or related field

Herramientas

Project management tools

Descripción del empleo

We are seeking a Senior Project Manager for Quality Applications to join our team in Basel. This critical role involves leading and overseeing the implementation and management of quality management systems, including DMS Cornerstone, Kneat, and Trackwise, within a pharmaceutical organization.

Responsibilities

• Develop and execute project plans for the implementation and enhancement of quality management applications
• Collaborate with cross‑functional teams to ensure alignment of quality systems with business objectives and regulatory requirements
• Manage project timelines, resources, and budgets to ensure successful delivery of quality application initiatives
• Conduct risk assessments and develop mitigation strategies for project‑related challenges
• Lead the validation and qualification processes for quality management systems
• Ensure compliance with GxP regulations, FDA guidelines, and EMA standards throughout project lifecycles
• Facilitate training and change management activities related to quality application implementations
• Prepare and present project status reports to senior management and stakeholders
• Continuously evaluate and improve project management processes and methodologies

Qualifications

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field with a minimum of 8 years of project management experience in the pharmaceutical industry
• Proven track record of implementing quality management systems and in‑depth knowledge of GxP regulations, FDA guidelines, and EMA standards
• Strong project management skills, including risk management, resource allocation, and the ability to lead cross‑functional teams
• Advanced proficiency in project management tools and methodologies; PMP certification preferred
• Outstanding analytical, problem‑solving, communication, and interpersonal skills
• Fluency in English