Senior Quality Operations Lead – GMP/cGXP, Remote

Fresenius Kabi Austria GmbH; Graz; Vor Ort; EUR 54.000 - 66.000; Vollzeit

Benefits dieser Stelle

Homeoffice

Jobticket

Canteen

Free parking space

Bikeleasing

Health promotion

Zusammenfassung

Fresenius Kabi Austria GmbH in Graz seeks an experienced Quality professional to lead GMP/GxP compliance across drug substances, products and combination products. You will oversee regulatory interactions and drive quality programs within a biotech/pharma setting.

The role requires 7+ years in quality, strong GMP knowledge, and fluency in English; German and French are an asset. An on-site LH environment with opportunities for career growth and international exposure is offered.

Qualifikationen

• Seven years of experience in a Quality function with increasing responsibilities in biotech, life sciences or pharmaceutical industry.
• Degree in a technical or engineering discipline (BA/BS, MA/MS or PhD).
• Strong understanding of ISO 9001, ISO 13485, ICH Q8/Q9/Q10 and cGMP for Pharmaceuticals and Combination Products including Biologics.
• Strong GMP knowledge and quality practices for biotech manufacturing processes.
• Experience with regulatory agencies such as FDA, EMA.
• Experience with third-party quality management.
• Excellent English communication; French and German are a plus.

Aufgaben

• Maintain up-to-date knowledge of cGxP regulations and applicable standards and implement requirements into SOPs and guiding documents.
• Manage GMP-compliant transition of Programs from development to commercial.
• Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product.
• Manage GMP compliance during Analytical Transfer activities.
• Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance and Drug Product.
• Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate.
• Manage GMP/GDP/MDR quality oversight of CDMOs, testing labs, medical devices suppliers, packagers and carriers.

Kenntnisse

Quality management

GxP compliance

GMP knowledge

Regulatory affairs

Leadership

Cross-cultural communication

Ausbildung

BA/BS in technical discipline

MA/MS or PhD in technical/engineering

Jobbeschreibung

Fresenius Kabi Austria GmbH in Graz seeks an experienced Quality professional to lead GMP/GxP compliance across drug substances, products and combination products. You will oversee regulatory interactions and drive quality programs within a biotech/pharma setting.

The role requires 7+ years in quality, strong GMP knowledge, and fluency in English; German and French are an asset. An on-site LH environment with opportunities for career growth and international exposure is offered.