Quality System Manager (sr)

Proclinical is seeking a dedicated Quality System Manager to join our client's team in Switzerland. In this role, you will focus on ensuring compliance with ISO/cGMP quality system requirements and relevant guidelines. Your expertise will be crucial in providing immediate support to operations and quality control staff, making independent quality-related decisions, and offering quality support to project teams.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Verify compliance with ISO/cGMP quality system requirements.
• Provide on-the-floor QA support to address compliance concerns.
• Make independent quality-related decisions based on regulatory knowledge.
• Audit internal quality system elements in manufacturing and operational areas.
• Oversee compliance of Change Controls, CA/PA, investigations, OOS, and deviations.
• Conduct external audits of suppliers/vendors/off-site facilities.
• Act as a customer interface during audits and communications.
• Manage special projects or QA compliance functions as agreed with QA management.
• Prioritize and manage multiple projects simultaneously.
• Lead and direct the work of others as needed.
• Review and approve validation documents and Master Batch Records.
• Perform review/release of batch records as required.

Key Skills and Requirements:

• Experience in QA for commercial drug substance/drug product or aseptic processing and cell therapy manufacturing.
• Knowledge of GMP compliance and Part 11 compliance preferred.
• Familiarity with international aseptic processing regulations.
• Strong written and oral communication skills, including documentation.
• Ability to work in a fast-paced, team-oriented environment with independent work skills.
• Proficiency in Microsoft Office and database management.
• Strong organizational and record-keeping skills.
• Ability to handle multiple projects and communicate directly with clients.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.