Manager Quality Officer

To strengthen our Global Affiliate Quality in Vienna, Austria, we are currently hiring a

Local Quality Officer (m/f/x)

(Fulltime / permanent / Location: Vienna)

The Opportunity

The purpose of the Local Quality Officer (LQO) role is to operate a local Quality system in the territory of responsibility in full compliance with all local requirements and company policies and to represent CSL Behring (CSLB) Quality within a specific country.

The Role

• Implements and maintains the Local Quality Management System (QMS) in compliance with local regulations and Global CSL Behring standards.
• Enforces the quality management system in all the quality activities of the affiliate. The quality activities include but are not limited to batch release, change control, complaints, and deviation management.
• Provides 3PL vendor oversight, and supports qualification, selection, and negotiation of new suppliers.
• Supports new product launches and ensures compliance of the existing lifecycle products.
• Acts as the primary point of contact to report or liaise about any recalls, field actions, or quality-related supply chain issues with batches delivered to the affiliate or region not meeting requirements.
• Ensures that all relevant affiliate personnel receive initial and ongoing training in compliance with CSL Behring requirements and local regulations.
• Acts as responsible person (Fachkundige Person) in line with authority requirements
• Participates in the local Commercial Operations Leadership Team meetings, monthly business review meetings and provides input to strategic planning and discussions at the local market level.

Your Skills and Experience:

• Degree in pharmacy or life science (if required by local legislation) or equivalent experience
• At least 5 years of experience in the pharmaceutical industry, of which 3 years of experience in Quality Management Systems.
• Understands and has experience in pharmaceutical quality assurance systems.
• Knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region
• Fluent in local language and good knowledge of oral and written English.

Reporting Relationship:

• This position reports to Quality Cluster Head

What we offer

• A comprehensive and inclusive benefits package, including options for life insurance and retirement plans.
• Two additional leave days for your personal wellbeing.
• Learning opportunities with our CSL Academy.
• Find Inclusion and Belonging at all sites and with every colleague. Come as you are

Join us and contribute to making a difference in the lives of patients with rare diseases. Apply today!

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL

Do work that matters at CSL Behring!