Head of Quality

**CordenPharma** ist eine der führenden Contract Development and Manufacturing Organizations (CDMO) und entwickelt und produziert im Auftrag ihrer Kunden als „Full-Service“-Dienstleister pharmazeutische Wirkstoffe, Arzneimittel und damit verbundene Verpackungsdienstleistungen. Die Gruppe beschäftigt rund 3.000 Mitarbeiter.

Unser Netzwerk in Europa und den USA bietet flexible und spezialisierte Lösungen für sechs Technologieplattformen: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules und Oligonucleotides. Wir streben nach Spitzenleistungen bei der Unterstützung dieses Netzwerks und engagieren uns für die Bereitstellung von Produkten höchster Qualität zum Wohle der Patienten.

**Our People Vision**:
We strive for excellence. We share our passion. Together, we make a difference in patients’ lives.

**Head of Quality**:
**Was dich erwartet**:
CordenPharma is making a bold move to expand its **Peptide Platform**, strengthening our position as a global leader in C**DMO peptide manufacturing**. A major milestone in this journey is the construction of a s**tate-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.

**Um diese Rolle erfolgreich zu meistern, suchen wir nach folgenden Qualifikationen**:

- 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.

**_

**Was wir dir bieten**:

- Dynamisches und spannendes Arbeitsumfeld
- Einen attraktiven Arbeitsplatz mit einer hohen Verantwortungsübernahme
- Flexible Arbeitszeiten
- Positives Arbeitsklima und offene Führungskultur mit Fokus auf kontinuierliche Verbesserung der Prozesse, um innovativ zu bleiben

**Interessiert?**:
Wenn du gerne im Team arbeitest und an einem abwechslungsreichen Aufgabenbereich inter