QA Senior Specialist

The Quality Operations team in our site in Leverkusen plays a key role in ensuring that our CDMO manufacturing and supporting activities are performed in line with the highest quality and GMP standards.

Working closely with Manufacturing, Quality Control, MS&T, Supply Chain and Engineering, the team provides hands-on Quality Assurance support across day-to-day site operations.

As QA Operations Senior Specialist, you will combine your Quality Assurance expertise with a strong operational and coordinating role.

You will help coordinate day-to-day activities within QA Operations, particularly across shift operations, and act as a key point of contact when quality questions or issues arise. Working closely with the QA Operations experts and other functions on site, you will help ensure that operational topics are addressed efficiently, with the right level of QA oversight and escalation when required.

An important part of the role is also about making the way we work better. Approximately 30% of your time will be dedicated to analysing, simplifying and improving operational processes, using practical experience as well as Lean and Operational Excellence principles.

In this role, you will:

• Coordinate day-to-day QA Operations activities and priorities, helping ensure effective QA support and continuity across shift operations.
• Provide hands-on QA oversight for GMP-related activities across Manufacturing and supporting functions such as QC, MS&T, Supply Chain and Engineering.
• Act as a first point of contact for operational Quality topics, working with colleagues to assess and resolve issues as close as possible to where they occur.
• Ensure that more complex or higher-risk quality issues are escalated appropriately and in a timely manner.
• Support key Quality Management System processes, including deviations, CAPAs, change controls, investigations and quality risk assessments.
• Review and approve relevant GMP documentation within your area of responsibility and authorization.
• Support new product introductions, technology transfers, validation activities and ongoing process verification.
• Contribute to internal and customer audits, regulatory inspections and self-inspections.
• Work closely with internal stakeholders, QA counterparts and customers on quality-related topics and cross-functional projects.
• Dedicate approximately 30% of your time to identifying opportunities to simplify processes, eliminate unnecessary complexity and improve operational efficiency, applying Lean and Operational Excellence principles.
• Actively contribute to a strong quality and GMP culture across the site.

For this position, we are looking for an experienced Quality professional who enjoys being close to operations and is comfortable coordinating activities and making sound decisions in a dynamic GMP environment, understanding aseptic processes.

Ideally, you bring:

• A Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or another relevant scientific discipline.
• At least 7 years of professional experience in a GMP-regulated environment, gained within areas such as Quality Assurance, Quality Control, Technical Services or Manufacturing.
• Strong hands-on experience in operational Quality Assurance.
• Flexible to work in shifts
• Good knowledge of GMP requirements and relevant regulatory expectations, such as EMA, FDA and ICH requirements.
• Experience with the development or manufacturing of biological products and an understanding of biologics production processes.
• Experience working in a manufacturing or shift-based environment. Previous experience coordinating operational activities or cross-functional teams would be an advantage.
• Strong organizational and communication skills, with the ability to set priorities, coordinate different stakeholders and facilitate effective handovers.
• A practical, solution-oriented approach to problem solving, combined with good judgement around when an issue can be resolved operationally and when escalation is needed.
• Experience with process improvement, Lean or Operational Excellence methodologies is highly desirable.
• Advanced German and Engish language skills are required.

This position gives you a particularly broad view of our operations. You will work across Quality, Manufacturing and several supporting functions, combining your QA expertise with coordination, problem solving and continuous improvement.

You can expect:

• A senior Quality role with significant exposure to day-to-day manufacturing operations.
• The opportunity to work across functions and contribute to important quality and operational decisions.
• Dedicated scope to improve and simplify processes rather than only maintaining existing ways of working.
• A collaborative environment where you can bring your experience, ideas and practical Quality expertise.
• Opportunities to grow as the site, production activities and Quality Operations organization continue to develop.

Jan Swinnen