Senior Manager Quality Operations (m/f/d)

Fresenius Kabi Austria; Graz; On-site; EUR 54,000 - 66,000; Full time

Benefits offered by this job

Homeoffice

Jobticket

Kostenlose Parkplätze

Bikeleasing

Canteen

Gesundheit & Prävention

Job summary

Fresenius Kabi Austria in Graz sucht eine erfahrene Fachkraft im Qualitätsmanagement, die cGxP-Vorschriften kennt und GMP-Standards in lokalen SOPs umsetzt. Sie steuern den Übergang von Programmen von Entwicklung zu Produktion und überwachen Transfers von Herstellprozessen.

Sie tragen Verantwortung für Change Controls, Deviationen, CAPAs und QM-Programme; idealerweise verfügen Sie über einen technischen Abschluss, ≥7 Jahre Erfahrung und gute Englischkenntnisse; Deutsch/Französisch von Vorteil.

Qualifications

• Abgeschlossenes Studium in technischer/ingenieurwissenschaftlicher Fachrichtung.
• Mindestens 7 Jahre Berufserfahrung in einer Qualitätsfunktion mit wachsender Verantwortung.
• Gute Kenntnisse der Qualitätsstandards (ISO 9001, ISO 13485, ICH Q8/9/10) und cGMP-Anforderungen.

Responsibilities

• Auf dem neuesten Stand bleiben bezüglich cGxP-Vorschriften und Standards; Umsetzung in SOPs und Dokumenten.
• GMP-konforme Transition von Programmen von Entwicklung zur Vermarktung.
• GMP-Compliance während technischer Transfers von Herstellprozessen.
• GMP-Compliance während Analytischer Transferaktivitäten.
• Interne/Externe Change Controls, Deviations, CAPAs usw. zu Drug Substance/Product/Combination Products.
• Beiträge zu QM-Programmen und GMP/GDP/MDR-Compliance.

Skills

Qualitätsmanagement

Regulatorische Kenntnisse

GMP/GDP

Führungskompetenz

Teamarbeit

Kommunikation EN/DE

Education

Technischer Hochschulabschluss (BA/BS oder höher)

Job description

• Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
• Manage a GMP compliant transition of Programs from development to commercial
• Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product
• Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
• Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
• Manage GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers
• A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
• Minimum seven years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
• Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
• Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
• Experience with regulatory agencies such as the FDA, EMA, etc.
• Proven success in third-parties’ quality management
• Excellent communication skills in English, both written and oral, French and German as an asset
• Demonstrated ability to work effectively in a team-oriented environment
• Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm

Your tasks

• Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
• Manage a 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, Drug Product and Combination Products
• Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
• Manage GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers

Our expectations

• A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
• Minimum seven years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
• Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
• Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
• Experience with regulatory agencies such as the FDA, EMA, etc.
• Proven success in third-parties’ quality management
• Excellent communication skills in English, both written and oral, French and German as an asset
• Demonstrated ability to work effectively in a team-oriented environment
• Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm

We offer

• Highly varied range of tasks
• Training opportunities and personal development within the company
• Career opportunities in an international pharmaceutical company
• Attractive, performance-based remuneration (minimum gross annual salary of € 60,000; higher salary depending on qualifications)

Benefits

• Reliable employer
• Strong global growth
• International career opportunities
• Comprehensive education and training
• Homeoffice
• Jobticket
• Active health promotion
• Free parking space
• Bikeleasing
• Canteen
• Joint company events

Fresenius Kabi Austria

Mag. Celina Gößler, MA

Hafnerstraße 36

8055 Graz