About the Position

Quality Assurance Manager* (m/w/d) Qualifizierung/Validierung

Vollzeit
Work Arrangement: Hybrid
Abteilung: Quality Assurance and Regulatory Affairs

Join Axolabs – Where Innovation Meets Impact in the Field of 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 to high-throughput screening and 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 an operational role – 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, collaborative environment as a CRO and CDMO.

Responsibilities

As a Quality Assurance Manager, you will:

In consultation with the Senior QA Manager or Head of QA:
- Conduct QA review and approval of URS, risk analyses, and qualification and validation documentation (DQ, IQ, OQ, PQ, CSV/CSA).
- Ensure GMP-compliant qualification and validation of equipment, devices, utilities, and computerized systems in accordance with Annex 15, Annex 11, and 21 CFR Part 11.
- Provide QA oversight for qualification, validation, requalification, and monitoring activities, including GMP-relevant utility systems.
- Assess risks and traceability between requirements, risk analyses, test cases, and qualification evidence in accordance with ICH Q9.
- Review and evaluate deviations, root cause analyses, CAPAs, and trend data regarding their impact on qualification and validation status.
- Conduct QA evaluation of technical changes and support risk-based qualification strategies and GMP-compliant decision processes.
- Represent QA in technical projects, including FAT, SAT, commissioning, startup, and GMP consulting for engineering and project teams.

Requirements

We are looking for:

A degree in Pharmacy, Chemistry, Biotechnology, Biology, Engineering, or a comparable technical/scientific field.
At least 2 years of GMP experience in qualification, validation, or quality assurance.
Solid knowledge of EU GMP Annex 15, Annex 11, ICH Q9, and GAMP 5.
Knowledge of ICH Q9 and risk-based qualification approaches.
Experience in the qualification of equipment, laboratory equipment, and GMP utilities.
Experience in reviewing URS, risk analyses, and IQ/OQ/PQ documentation.
Experience in interdisciplinary projects with engineering, production, QC, and QA.
Experience with FAT/SAT participation.
Very good IT skills, especially MS Office.
Experience in pharmaceutical production and/or analytics is desirable.
Knowledge of chemical/biochemical/microbiology analytics is desirable.
Excellent written and spoken German and English skills.
High commitment, strong communication skills, resilience, reliability, teamwork, and a sense of responsibility.

Nice to Have

Experience in the pharmaceutical industry and/or analytics.

We Offer

Comprehensive onboarding and mentoring for a successful start.
The opportunity to help build our new location.
Permanent contract, company pension plan, and attractive employer contributions.
Responsible tasks and individual development and career opportunities in an innovative, international company.
Open company culture where integrity, respect, passion, and curiosity for future-oriented, creative solutions are at the center.
Relocation assistance for candidates from outside the region.
30 days of annual leave.
Subsidized job ticket (Deutschlandticket).

We place great emphasis on collaboration and believe that success is best achieved through teamwork and open communication. Join our team now. We look forward to your application!

About the Company

About LGC:

LGC is a leading global life sciences 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 typically embedded in our customers' products and workflows and are valued for their performance, quality, and broad range.

Our Values:

Passion
Curiosity
Integrity
Brilliance
Respect

Equal Opportunity:

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

#Axolabs

Job Location

Berlin, Germany

Kulmbach, Germany

Petaluma, USA

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Quality Assurance Manager* (m/w/d) Qualifizierung/Validierung

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