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Quality Assurance Manager for Regulatory Compliance and Process Improvement
vor 2 Monaten
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. We're a community of innovators, thinkers, and doers who share a passion for making a meaningful impact.
Job Summary
We're seeking a highly skilled Quality Assurance Manager to join our team in Darmstadt, Germany. As a key member of our quality assurance team, 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
- Collaborate with cross-functional teams to implement process improvements and optimize quality control processes
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
- Access to learning and development opportunities, training programs, and coaching and mentoring programs
- Inclusive work environment that values diversity and promotes work-life balance
Location
Darmstadt, Germany
