Purpose:

The purpose of the Regional Quality Officer (RQO) role is to act as the GDP Responsible Person for Poland and to operate Quality system in the territory (including Czech Republic, Slovakia and Hungary) responsibility in full compliance and to represent CSL Behring (CSLB) Quality in the assigned affiliates/branch office or distributor markets as well as towards CSL Behring manufacturing sites QA and CSL Global Quality

QA (Quality Assurance) Support – QA activities & Management

Implements and maintains the Quality Management System (QMS) in compliance with all regulations (international, local) and Global CSL Behring standards in the assigned affiliates/branch offices or distributor markets

The quality activities include but are not limited to batch release, change control, complaints, and deviation management.

Provides 3PLs/distributors 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 assigned affiliates/branch office or distributor markets.

Ensures that all relevant affiliate/branch office or distributor personnel receive relevant training in compliance with CSL Behring requirements and applicable regulations (including, but not limited to, relevant GxP trainings, deviation, and complaint management, change control and label change management, CSL Behring system and processes, etc.).

Local engagement – Cross-functional engagement

Participates in the local Commercial Operations Leadership Team meetings, periodic business review meetings and provides input to strategic planning and discussions.

Primary point of contact to and from Global or Regional Quality, ensuring a timely, two-way communication above country and in market.

Collaborates with other affiliates and Global Quality group to benchmark best quality practices to mature quality culture for the affiliate the RQO is responsible for.

Main responsibilities:

Implementation and maintenance of the Quality Management System in compliance with local regulations and CSLB standards, including but not limited to:

Deviation Management

Corrective Action & Preventive Action (CAPA) Management

Product Complaints Management

Change Control Management,

Documentation Management

Training Management

Recall Management

Self-Inspection Management

Quality Risk Management

And recommendation for improvements to the quality system supporting CSLB business in the countries

Qualifications:

Degree in pharmacy or life science (if required by local legislation) or equivalent experience

At least 5-7 years of experience in the pharmaceutical industry, of which 4 years of experience in Quality Management Systems and in warehouse management.

Fluent in local language in the assigned affiliates/branch office or distributor markets and good knowledge of oral and written English.

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.

Our Benefits

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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

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