Project Quality Manager (m/f)

REFERENZNUMMER:

241089/11

IHRE AUFGABEN:

-Manage the quality and compliance requirements for the projects establishing appropriate tasks and timelines within each phase of the project planning process to ensure the compliant development and execution of the project
-Have a deep understanding of cGMP guidelines to be able to evaluate project decisions and conduct risk analysis ensuring that each phase of the project complies with the guidelines and current companies and regulatory requirements
-Ensure quality specific tasks are completed in a timely manner respecting project milestones and budget considerations
-Establish a solid network on-site and within the companies scientific network to facilitate the sharing of best practices and to proactively and effectively leverage learnings as part of the project planning process

IHRE QUALIFIKATIONEN:

-University degree in Engineering, Science or Quality Management applied to industrial process
-Profound working experience, with deep proven knowledge of quality experience in the regulated biologic or drug product manufacturing industry
-Very good understanding of cGMP requirements
-Hands-on experience working on pharmaceutical audits, regulatory affairs submissions or addressing compliance needs
-Experience in project management
-Knowledge of FDA, EMA, Swiss regulations & quality systems related standards: 21CFR210/211, EU Guide Vol 4, PIC/S, industry related guidelines
-Fluent in English (comprehension, written and spoken), French is an advantage
-Excellent interpersonal, communication, influencing and negotiation skills
-Strong negotiator with an emphasis on finding win-win solutions

WEITERE QUALIFIKATIONEN:

Quality manager