Internal job advertisement 

Department: 

Location: Muttenz

Quality System Manager (m/f/d)

• ​Muttenz
• ​01.10.2025
• ​Full-time
• ​Permanent

CordenPharma is making a bold move to expand its Peptide Platform, strengthening our position as a global leader in CDMO peptide manufacturing. A major milestone in this journey is the construction of a state-of-the-art peptide manufacturing facility in Muttenz, Switzerland – located just outside Basel, a major biotech and pharma hub.

We are currently looking for a motivated and experienced Quality System Manager to help us establish and maintain a robust Quality Management System (QMS) from the ground up.

As Quality System Manager, you will play a key role in designing, implementing, and maintaining the QMS that ensures compliance, efficiency, and audit readiness at our new site. You will lead essential quality processes and serve as a subject matter expert for audits, electronic systems, and supplier qualifications.

Your tasks will include:

• Lead and manage the creation, implementation, and continuous improvement of the new site’s Quality Management System (QMS).
  
• Ensure the QMS is compliant with applicable GMP regulations, Corporate standards and global regulatory requirements.
• Own and oversee core quality system processes, including but not limited to Deviation and CAPA Management, Change Control, Self-Inspection, External Audits, Document Control and Records Management, Training Program, Quality Risk Management.
• Manage the document control system to ensure timely review, approval, and version control of SOPs, protocols, reports, and batch documentation.
• Develop and execute a site inspection readiness program.
• Drive or contribute to quality improvement initiatives (e.g., QMS harmonization, digitalization, regulatory gap assessments).
• Monitor and report on Quality KPIs related to system health, compliance metrics, and audit performance.
• Develop and execute a Supplier Qualification Program, including supplier qualification audit, Quality Agreements, SCAR and follow up of the supplier’s CAPA.
• Act as the subject matter expert (SME) for quality systems during client and regulatory audits.
• Collaborate with IT and QA teams to maintain and optimize electronic quality systems (e.g., TrackWise, D3, Power Bi, etc.).
• Support tech transfer, process validation, and new project onboarding from a quality systems perspective.

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or a related discipline.
• 7+ years of experience in GMP-regulated pharmaceutical quality, with at least 3 years focused on quality systems; prior experience in a CDMO environment is strongly preferred.
• Strong working knowledge of global GMP regulations (e.g., FDA, EMA, Swissmedic).
• Demonstrated experience in implementing and managing electronic quality systems.
• Strong experience with audits (regulatory and client) and associated CAPA management.
• Demonstrated experience managing client interactions and audits
• Fluency in German and English; additional European languages are an asset

Why Join Us?

🚀 Be part of a greenfield site and shape the foundation of our Quality culture
🤝 Work in a collaborative, science-driven and international environment                                                                     📈 Enjoy growth opportunities, modern infrastructure and a dynamic team culture

🔹 Ready to Make an Impact?

We look forward to receiving your complete application - including your CV, motivation letter, diplomas and work certificates - and to welcoming you as part of our growing team in Muttenz !

Please note that unsolicited applications from recruitment agencies will not be considered.