Senior Scientific Expert QA Filling - #49272

Entity: CSL Behring

Job Category: Quality

Job Family: Quality Assurance

Job Type: Part Time

Location: Bern, Berne, Switzerland

Employer Reference: R-276992

Job Description

Product quality and patient safety are at the heart of everything we do. As part of the Quality Assurance division within the Filling department, you will ensure compliance with GMP requirements, support product release activities, and contribute to the continuous improvement of aseptic manufacturing processes. In this role, you will serve as a key partner to Manufacturing, Quality functions, and regulatory authorities in a fast-paced and highly regulated environment

Responsibilities:

• Under general supervision, maintain Quality Assurance System to ensure compliance with company and cGMP standards.
• Review and approve GMP documentation, batch records, and release documentation to ensure compliance with internal and regulatory requirements.
• Manage deviations, investigations, and quality-related decision-making in collaboration with cross-functional stakeholders.
• Support authority inspections and prepare responses to regulatory questions from agencies such as Swissmedic and FDA.
• Ensure SOPs, quality systems, and GMP processes remain compliant with current regulatory expectations.
• Deliver GMP training and promote quality awareness throughout the organization.

Qualifications:

• Master's degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related scientific discipline required.
• At least 3 years of GMP experience in Quality Assurance, aseptic manufacturing, filling operations, or a comparable regulated environment.
• Experience supporting batch release, deviation management, inspections, and GMP compliance activities preferred.
• Strong understanding of GMP requirements, Annex 1, and aseptic manufacturing principles.
• Experience interacting with regulatory authorities (FDA, EMA, Swissmedic) or supporting inspections is an advantage.
• Fluent German required; strong English communication skills a plus.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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.

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/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

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

Equal Opportunity Employer

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.