Senior Quality Project Manager - Applications (DMS, Cornerstone, Kneat, Trackwise)

We are seeking a Senior Project Manager for Quality Applications to join our team in Basel, Switzerland. In this role, you will lead and oversee 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

• 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 ability to lead cross-functional teams
• Technical knowledge of the applications (DMS, Cornerstone, Kneat, Trackwise) from a project management perspective
• Outstanding analytical, problem-solving, communication, and interpersonal skills
• Fluency in English