Innerbetriebliche Stellenausschreibung 

Abteilung: 

Ort: Muttenz

Eingruppierung: 

Ausschreibung ab: 
Ende der Ausschreibung: 

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.
To support this exciting growth, we are seeking a Head of Quality to build and lead our Quality organization from the ground up. This is a unique opportunity to shape the Quality function during a greenfield project and play a strategic role in bringing the site to operational excellence.

Your tasks will include:

• Develop and implement the Quality department’s strategy, providing direction and guidance to the project team during the construction and the commissioning of the Muttenz API manufacturing site.
• Perform project deliverables review and provide quality oversight to external engineering, commissioning and qualification companies. This includes the validation/qualification strategy and approval of protocols and reports.
• Ensure site compliance with all applicable regulatory requirements, including Swissmedic, EMA, US-FDA, and other global health authorities.
• Hire, lead and manage the Quality Assurance and Quality Control teams at the new manufacturing site.
• Own and continuously improve the site's Quality Management System (QMS), including document control, change control, deviation management, CAPA, training, risk management, audit, qualification and validation.
• Coordinate with business development and project management teams to support new project introduction.
• Provide quality input for technology transfers and validation activities.
• Ensure that all activities are performed in accordance with GMP, Corporate standards and Health and Safety policies.
• Oversee product release processes and ensure timely and compliant quality control testing and batch disposition.
• Manage customer relationship, by hosting audits and ensuring their expectations are met as required. Review and approve Quality Agreements.
• Act as primary contact point towards local and international regulatory agencies in case of regulatory inspections, license upgrade and site modifications, as required.
• Drive a culture of quality, compliance, and continuous improvement across the site.
• As member of local Leadership Team, participate in and support cross-functional leadership and strategy meetings.
• Develop and manage departmental budgets and resource planning.

• University degree (BSc/MSc) in Chemistry, Pharmacy, Chemical Engineering or related field.
• 10+ years of experience in GMP pharmaceutical manufacturing, including at least 5 years in a senior Quality leadership role.
• Solid understanding of cGMP and regulatory standards for API production.
• Proven ability to lead inspections and audits with international customers and health authorities.
• Strong leadership and interpersonal skills, with a collaborative mindset.
• Experience with electronic quality systems (e.g., TrackWise, LIMS, SAP) preferred.
• Familiarity with Lean, Six Sigma, or Operational Excellence tools is a plus.
• Fluent in German and English; other European languages are an asset.

Why Join Us?

🚀 Be s strategic leader in one of the most exciting CDMO growth projects in Europe
🏗️   Shape and scale a quality organization from day one.
🤝 Work in dynamic, international and science-driven environment.

🔹 Ready to Make an Impact?

If you're ready to make a meaningful impact and lead with passion and purpose, we'd love to hear from you.

📩 Apply today by submitting your CV, motivation letter, work certificates, and diplomas.
 

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