Senior Manager Quality Operations (m/f/d)

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

Benefits dieser Stelle

Performance-based remuneration

Training and personal development

Career opportunities in international

Zusammenfassung

Fresenius Kabi Austria GmbH is seeking a Senior Manager Quality Operations (m/f/d) to ensure cGxP compliance and oversee GMP/GDP/MDR activities for Drug Substance, Drug Product, and Combination Products. The role requires strong leadership, regulatory experience, and a track record in biotech, life sciences, or pharmaceutical quality.

Key responsibilities include managing transitions from development to commercial, overseeing third-party quality oversight, and driving QMS improvements with

Qualifikationen

• Up-to-date knowledge of cGxP regulation and applicable standards and implement into SOPs and guiding documents.
• Experience in GMP transition of programs from development to commercial.
• GMP oversight of CMOs, testing labs, and suppliers.
• Strong understanding of ISO 9001, ISO 13485, ICH Q8/Q9/Q10 and cGMP for pharma products.

Aufgaben

• Maintain up-to-date knowledge of cGxP regulations and implement into procedures.
• Manage GMP compliant transition of programs from development to commercial.
• Oversee GMP compliance during tech transfer of manufacturing activities.
• Lead internal and external change controls, deviations, events, CAPAs related to drug substances, products, and combos.

Kenntnisse

cGxP knowledge

GMP compliance

Regulatory affairs

Quality management

Leadership

English proficiency

French/German asset

Ausbildung

BA/BS or higher in technical/engineering

Jobbeschreibung

Senior Manager Quality Operations (m/f/d)

• 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

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)