Local Quality Officer (m/f/x)
Local Quality Officer (m/f/x)
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Job Description
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. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
