Lead Quality Assurance Specialist

vor 4 Wochen

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

Position Overview

We are currently seeking a dedicated professional for our Quality department.

Role: Lead Quality Assurance Specialist (m/w/x)

Employment Type: Full-time / Permanent / E12T Tariff

Internal Title: Lead Quality Assurance Specialist

As a key contact for Research & Clinical Bioanalytics (RCB MBR) in both local and global multi-site GLP studies, this individual will ensure compliance and enhancement of the quality management system in accordance with local and regulatory standards.

Key Responsibilities:

  • Act as the primary liaison for RCB MBR in all local and global multi-site GLP studies.
  • Ensure adherence to and advancement of the quality management system in line with local and regulatory guidelines, policies, and standards in Research & Development (e.g., OECD principles of Good Laboratory Practice (GLP) and ISO).
  • Organize and conduct cross-departmental training sessions.
  • Develop, update, and manage the annual plan for internal inspections in accordance with ISO 17025 and GLP.
  • Prepare, execute, document, follow up, and track internal inspections.
  • Create, review, and approve policies/SOPs/WIs both locally and globally within the area of responsibility.
  • Review and approve (regulatory relevant) plans and reports.
  • Continuously improve established processes, standards, and quality management systems.
  • Provide guidance on compliance with quality assurance guidelines for local and global projects.
  • Serve as a resource for global and local teams regarding all quality assurance matters within the area of responsibility.

Qualifications and Experience:

  • Typically, a completed Bachelor of Science degree, e.g., in Biology.
  • 4-5 years of professional experience in a relevant field.
  • In-depth experience in the GxP environment within the pharmaceutical industry, preferably in (pre-)clinical research/quality.
  • Strong knowledge and experience in OECD GLP and/or ISO 17025.
  • Extensive experience in inspection management (both internal and external) and regulatory affairs.
  • Proficient in English (Level 2).

Our Benefits:

  • Attractive compensation and additional benefits under the collective agreement of the chemical industry in Hesse (including Christmas and vacation bonuses, as well as discretionary bonus payments).
  • Two additional vacation days for personal well-being.
  • CSL subsidized cafeteria offering a variety of main courses, desserts, and snacks.

About CSL Behring:

CSL Behring is a global leader in the development and delivery of high-quality medicines that treat individuals with rare and serious diseases. Our therapies provide hope for patients in over 100 countries dealing with conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Diversity and Inclusion:

As a global organization with employees in over 35 countries, CSL values diversity and inclusion. We are committed to creating a workplace that reflects the world around us.

Join Us:

At CSL Behring, you will have the opportunity to contribute to meaningful work that makes a difference in the lives of patients worldwide.

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