Group Quality Api Manager

vor 1 Tag

Basel, Schweiz CordenPharma Vollzeit

CordenPharma ist ein führender Anbieter für die Entwicklung und Herstellung von pharmazeutischen Wirkstoffen (APIs), Hilfsstoffen, Fertigarzneimitteln und Verpackungsaktivitäten mit mehr als 2.800 Mitarbeitenden weltweit. Mit unseren Dienstleistungen unterstützen wir Pharma
- und Biotech-Unternehmen bei der Herstellung von Medikamenten mit dem vorrangigen Ziel, das Leben der Menschen zu verbessern.

Unser Netzwerk in Europa und den USA bietet flexible und spezialisierte Lösungen auf sechs Technologieplattformen: Peptides, Oligonucleotides, Lipids & Carbohydrates, Injectable, Highly Potent & Oncology; and Small Molecules. Wir sind bestrebt in all diesen Bereichen höchste Qualität zum Wohl der Patienten zu liefern.

Zum nächstmöglichen Zeitpunkt suchen wir am Standort Basel eine/n

**Group Quality API Manager (M/F/d)***:

- Basel
- as soon as possible
- Vollzeit
- unbefristet

**Ihr spannendes Aufgabengebiet**:

- Collaborate with local quality departments to ensure GMP readiness of new and legacy API facilities include pre-licensing preparation, efficient startup and product lifecycle management.
- Collaborate with cross-functional teams to ensure quality operations compliance with local and global quality regulations during the development, manufacturing, and release of APIs.
- Conduct KPI surveillance and internal audits to elevate particular areas of risk or concern for APIs production and enforce remediation action to support inspection readiness and increase API process robustness.
- Act as a Subject of Matter Expert for GxP compliance of API quality operations & analysis and drive for further digitalization.
- Support the local quality organization in executing the Quality Culture Program and adopting Quality behaviors.
- Master the complexity of the API manufacturing processes within the group and understand the potential sources of variability using the digital GxP systems.
- Collaborate in Quality ad-hoc boards in case of API related Escalations to Management, immediately after being notified by a site, to ensure and support timely actions, effective communication, thorough investigation and effective CAPAs.
- Provide expertise in the implementation and optimization of global quality systems across API
- manufacturing sites.
- Provide training and expertise to global teams on quality requirements, GMP practices, and industry regulations.
- Lead and support the global harmonization of local quality management systems, ensuring they meet regulatory and internal requirements for API manufacturing.
- In collaboration with the Operational Excellence department, foster a culture of quality excellence by driving continuous improvement initiatives and best practice sharing across the global network.

**Ihr Profil**:

- University degree in Chemistry, Pharmacy, Biology, Engineering or other technical/natural scientific area.
- Minimum of 5-8 years of work experience in manufacturing, quality control, quality assurance or other relevant area, in an API producing pharmaceutical/ CDMO company
- Profound knowledge of EU GMP and FDA regulations.
- Experience with electronic Lab, Quality and Documentation Management Systems
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment.
- High carefulness and accuracy in the way of working, conscientiousness and detail-orientation, strong ability to systematically gather and analyze data.
- Strong interpersonal and communication skills, capable of influencing and collaborating with cross-functional teams globally.
- Fluent in English. French, Italian or German are an asset.
- Available to international travels up to 20%.

**Was wir Ihnen bieten**:
**Flexible work hours***:
**Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative***:
**Dynamisches und spannendes Arbeitsumfeld***:
Corden Pharma bietet Ihnen interessante und vielseitige Aufgaben in einem hoch motivierten Team. Durch eine praxisorientierte Einarbeitung helfen wir Ihnen, schnell fachliche Sicherheit zu gewinnen, um selbstständig mit hoher Eigenverantwortung arbeiten zu können.

Wir freuen uns auf Ihre Bewerbungsunterlagen.

**Mirjam Engel**

Talent Acquisition Manager
- Zurück Bewerben

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