Job Description
Your Role:
* Maintain and improve the Quality Management Systems (QMS) strategy and related Standard Operating Procedures (SOPs).
* Ensure that relevant procedures are implemented, periodically reviewed, and aligned with best practices and legislations.
* Support continuous improvement of QMS within areas of responsibility and coordinate relevant training activities.
* Collaborate with Operational teams to ensure all activities meet quality specifications.
* Participate in and approve risk assessments related to areas of responsibility.
* Support the review and approval of Documentation systems.
* Support Health Authorities' inspections, internal and/or external audits, and evaluate actions with the Global Response Team (GRT).
* Provide backup support for other quality systems to ensure flexibility of the overall QMS team.
Qualifications
Your Profile:
* Bachelor's degree in a scientific discipline and 2-5 years of experience in a pharmaceutical/biotechnology environment.
* Experience establishing or improving QMS systems as an operational Subject Matter Expert (SME).
* Familiarity with Health Authority regulations.
* Proficiency in IT systems, including CARA, TW, GxP Manager, GLIMS, SAP Lean, etc.
* Excellent communication skills, teamwork, adaptability, and proactive approach to quality.
* Analytical and problem-solving abilities with a proactive attitude towards quality.
* Organized and logical project management skills.
* Fluency in English is mandatory; knowledge of French is beneficial.