Quality Assurance Manager*in - GMP (m/w/d)
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Job description
About the Position
Quality Assurance Manager*in - GMP (m/w/d)
- Work Arrangement: On-site
- Department: Quality Assurance and Regulatory Affairs
About the Company
Join Axolabs – Where Innovation Meets Impact in RNA Therapeutics
At Axolabs, you will work in an international team that is making groundbreaking advancements in the development of nucleic acid-based medicines – from computer-aided drug development through high-throughput screening to large-scale manufacturing.
Our interdisciplinary teams combine expertise in oligonucleotide chemistry, bioinformatics, molecular biology, process engineering, analytics, and regulatory support. Whether you are a scientist, technician, data expert, or in the operational field – your work contributes to improving the health of people worldwide.
With locations in Petaluma (USA), Kulmbach, and Berlin (Germany) and as part of the LGC Group, we offer you a global, cooperative environment as a CRO and CDMO.
Responsibilities
- Ensure quality assurance in the GMP control laboratory and support the GMP-compliant release of therapeutic molecules
- Review documents and data for quality and compliance and support validations and qualifications
- Actively shape the continuous improvement of processes and the quality management system
- Support OOS cases, deviations, CAPAs, and change control processes
- Accompany internal, external, and supplier audits and conduct training for employees
Requirements
We are looking for
- A completed education in a scientific field (e.g., biochemistry, biology, biotechnology, chemistry, pharmacy), in the pharmaceutical-medical field, or a comparable qualification
- Professional experience in a GLP-, GCP-, GMP-, or ISO 13485-regulated environment, e.g., quality control laboratory, pharmaceutical industry, MedTech, accredited laboratory
- Independent, structured, and committed work style with strong communication skills
- Reliability, teamwork, and a sense of responsibility
- Proficiency with standard software and excellent German and English language skills
Nice to Have
- Experience with documentation
- Experience with validation
- Experience with process improvement
- Experience with training
- Experience with audits
We Offer
- Structured onboarding and mentoring for a successful start
- A full-time position (40 hours/week) with a flexible working time account
- An indefinite employment contract and a centrally located workplace in Kulmbach
- Responsible tasks and individual development and career opportunities in an innovative, international company
- Company pension plan, subsidies such as JobRad, and access to corporate benefits
- 100% coverage of the job ticket costs (Deutschlandticket) or free parking in the adjacent parking garage
- 30 days of annual leave
- Relocation support for applicants from outside the region
At Axolabs, we rely on cooperation, trust, and open communication. Join our team and shape the future of innovative RNA therapeutics with us.
We look forward to getting to know you!
Additional Information
ABOUT LGC
LGC is a leading global life science company that provides mission-critical components and solutions for high-growth areas in human medicine and other markets worldwide. Our high-quality product portfolio consists of mission-critical tools for genome analysis and quality assurance applications, which are usually embedded in the products and workflows of our customers and are valued for their performance, quality, and broad spectrum.
OUR VALUES
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
EQUAL OPPORTUNITIES
LGC is committed to openness, mutual respect, and equal employment opportunities regardless of ethnic or social origin, gender, age, religion, any disabilities, or sexual orientation and identity. We are committed to an inclusive culture and firmly believe that the diversity of individual values and perspectives drives the success and quality of our work.
We are constantly growing and are actively looking for people who want to make a difference with passion. More information about LGC and our job openings at www.lgcgroup.com
#scienceforasaferworld
Job Location
Kulmbach, Germany
Apply Now
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