Senior Quality Operations Leader, GMP & Regulatory

Fresenius Kabi Austria GmbH; Sankt Marein bei Graz; On-site; EUR 54,000 - 66,000; Full time

Benefits offered by this job

Performance-based remuneration

Training and personal development

Career opportunities in international

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

cGxP knowledge

GMP compliance

Regulatory affairs

Quality management

Leadership

English proficiency

French/German asset

Education

BA/BS or higher in technical/engineering

Job description

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