Senior Manager Quality Operations (m/f/d)

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

Benefits offered by this job

Homeoffice

Jobticket

Canteen

Free parking space

Bikeleasing

Health promotion

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality management

GxP compliance

GMP knowledge

Regulatory affairs

Leadership

Cross-cultural communication

Education

BA/BS in technical discipline

MA/MS or PhD in technical/engineering

Job description

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