Quality Assurance Manager for Regulatory Compliance and Process Improvement

vor 2 Wochen


Darmstadt, Hessen, Deutschland Bayer Vollzeit

About Bayer

Bayer is a global leader in the life sciences industry, driven by a vision to make a difference in the world by solving some of the toughest challenges in healthcare and agriculture.

Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team in Darmstadt, Germany. As a Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our analytical methods and processes.

Key Responsibilities

  • Develop and implement quality control procedures to ensure compliance with regulatory requirements
  • Review and approve SOPs and quality control qualification documents
  • Manage and investigate deviations, out-of-specification (OOS), CAPAs, and quality control changes
  • Represent quality assurance in cross-functional teams and projects
  • Provide support in coordinating approval and implementation of change projects across the site

Requirements

  • University degree in a natural sciences degree program
  • Several years of professional experience in the GMP-regulated area, preferably in a role in the field of quality
  • High degree of accuracy in dealing with national and international regulations (GMP, ICH, EMA)
  • Excellent communication and analytical skills as well as a high level of quality awareness, proactivity, and reliability
  • Good (cross-functional) teamwork skills
  • Very good written and spoken German and English skills

What We Offer

  • Competitive compensation package
  • Flexible work arrangements, including hybrid work models and part-time arrangements
  • Family-friendly benefits, including company daycare centers and support for childcare
  • Opportunities for professional growth and development, including training programs and coaching
  • A supportive and inclusive work environment


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