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To strengthen our Global Affiliate Quality in Vienna, Austria, we are currently hiring a
Local Quality Officer (m/f/x)
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!
We encourage you to make your well-being a priority. It’s important and so are you.
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