Senior QA Scientist - Product Release

Innovative and committed to patients worldwide.

CSL Behring is a leading global biotechnology company committed to its promise to save lives. At our site in Bern, with over 1'500 employees, we develop and produce life-saving therapies for people with severe and rare diseases worldwide.

For our QA Batch Release team within our Quality Management, we are looking for an experienced personality as

Senior QA Scientist - Product Release (100%) (m/f/d)

In this scientific Quality Assurance function, you will contribute to the GMP-compliant and timely release of our end products, thereby ensuring that our high quality standards as well as the relevant regulatory requirements are met.

In addition to operational product release, you will participate in the further development of our release processes and quality systems, support the introduction of products into new markets, and represent your area of responsibility during audits and inspections. In doing so, you will work in a regulated environment and regularly exchange information with internal interfaces as well as national and international health authorities.

Competencies and responsibilities

• GMP-compliant and timely release of end products according to applicable cGMP requirements, regulatory specifications, and SOPs.
• Creation, review, and updating of SOPs and specifications within the area of responsibility.
• Support in the introduction of new and existing products into new markets, taking into account the relevant quality and regulatory requirements.
• Participation in the further development and maintenance of an efficient and GMP-compliant release system.
• Representation of the Product Release area during regulatory audits and inspections, as well as support in the corresponding preparation and execution.
• Participation in and independent management of intra-departmental projects.
• Active support in the optimization of business and quality processes within the area of responsibility.

Qualifications and professional experience

• Completed Master's degree in pharmacy, biology, chemistry, or a comparable scientific field, or an equivalent qualification.
• Several years of relevant professional experience in the pharmaceutical industry.
• Sound knowledge of Good Manufacturing Practices (GMP) and experience in a correspondingly regulated environment.
• Experience in the field of Quality Assurance and/or Product Release is an advantage.
• Strong analytical and networked thinking skills as well as a careful and structured way of working.
• Independent, proactive, and solution-oriented way of working with the ability to take responsibility for one's own topics and tasks.
• High flexibility as well as enjoyment of working in a team-oriented environment.
• Open and professional communication style when dealing with various internal and external contact persons.
• Very good German and English skills in spoken and written form.
• Proficient use of MS Office as well as relevant quality systems.

About this position

• As part of our QA Batch Release team, you will take on an important role in ensuring the quality and GMP-compliant release of our end products. In doing so, you combine operational Quality Assurance tasks with the further development of processes and systems as well as participation in demanding projects.
• The position also offers you the opportunity to participate in topics with international and regulatory relevance - for example, when introducing products into new markets or within the framework of audits and regulatory inspections. Regular contact with national and international health authorities is an integral part of the work environment.

Do you see yourself in this position? Then we would be happy to receive your CV, your work references, and your diplomas as an application.

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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

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.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.