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CSL

Develops and delivers biotherapies and vaccines

Scientific Expert: Quality Assurance Support Functions

Regulatory & Quality (Life Sciences)Updated on Nov 15
Full-timeBern, SwitzerlandNo salary listedIn-person

About the Job

Requirements

  • A completed Master's degree in a natural science field such as Life Science, Biology, Chemistry, or Pharmacy, or a degree in engineering or law.
  • Excellent German proficiency at C2 and advanced English proficiency at C1, both written and spoken.
  • Good IT user skills.
  • An analytical mindset and the ability to quickly understand complex relationships and present them clearly and logically.
  • A high degree of independence and initiative.
  • A high sense of responsibility and enthusiasm for the work.
  • Ability to collaborate in a team-oriented way with other departments.

Responsibilities

  • Review and ensure compliance with GMP requirements in quality control, stability studies, maintenance and utilities (including requalifications and revalidations), warehousing, and internal transport.
  • Manage and approve deviations; lead initial risk assessments; support deviation owners in investigating root causes and defining corrective actions; assess product and process risks; and support completion of deviation investigation reports in German or English.
  • Manage change requests as a Quality Delegate, support change-request coordinators, classify and approve change requests, provide quality oversight of assessments and actions, approve closure, move change requests to implementation status, and participate in the global change-request panel.
  • Support quality decisions on the floor in the specified operational areas to ensure compliance, including periodic walkthroughs in areas such as warehousing with operational teams.
  • Participate in periodic meetings with the operational areas to ensure deviations, corrective actions, and GMP-relevant changes are completed on time.
  • Support the relevant team during regulatory authority inspections.
  • Conduct expert reviews and approve GMP documents for the specified specialist areas.
  • Support the optimization of systems and processes.

Desired Qualifications

  • Initial experience in deviation and CAPA management in a GMP environment, and written and oral communication with regulatory authorities.
  • Technical expertise in maintenance and utilities, analytical methods, stability studies, or warehousing and logistics processes.

About the Company

cb

CSL

Develops and delivers biotherapies and vaccines

CSL is a global biotechnology company that develops and delivers biotherapies and influenza vaccines. It focuses on plasma-derived and recombinant therapies for rare and serious diseases and sells to healthcare providers, hospitals, and governments across the Americas, Asia Pacific, and Europe. Its product range includes treatments for rare diseases, influenza vaccines, and antivenoms, produced through its R&D, manufacturing, and distribution operations. CSL differentiates itself by offering the broadest portfolio of plasma-derived and recombinant therapies and by leveraging its global footprint and emphasis on diversity to reach diverse markets. The company’s main goal is to save lives and protect health by expanding access to high-quality therapies and vaccines worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Parkville, Australia
Founded
1916

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