QA Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

We are looking for a QA Manager in the Quality Assurance Department for Quality Control (QAfQC). The Quality Unit in Kaiseraugst/Basel consists of Quality Assurance (QA), Quality Control (QC), Quality Systems (QS), as well as Quality Compliance and Issues. We guarantee the quality and compliance of over 40 product families for more than 120 countries in an integrated drug product and packaging location. We are also responsible for the centralized QC and the performed release and stability tests of sterile and non-sterile products as well as raw and packaging materials.

Our philosophy is that quality is every patient's right, and we take responsibility for it and contribute our part to it. Career Opportunities

The Opportunity

As a QA Manager, you will share the responsibility with your colleagues within the QA team to ensure that our products meet the specific requirements and that the analytics and approvals comply with the legal requirements in the customer markets as well as with the internal Roche Pharma Quality Standards (PQS) requirements. You are an expert in all quality-related issues and the link between quality control and other relevant interfaces.

• Ensuring quality oversight in QC through, among other things, conducting QA inspections and participating in and supporting self-inspections and authority audits.
• Reviewing and approving qualification and validation reports in the area of laboratory equipment, systems, and CSV.
• QA responsibility and processing of deviation reports, CAPAs, and changes.
• Introducing and implementing ideas to improve the quality and efficiency of processes as well as cost reduction. Drive improvements using Lean Production System (LPS) methods and tools and live them in daily business.
• Close cooperation with internal and external interfaces to achieve our ambitious goals for quality, lead time, engagement, and costs.
• Training and taking over new activities in neighboring areas in the sense of a polyvalent development.
• Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety.
• Creation, approval, and training of SOPs and other GMP-relevant documents and processes.

Who You Are

You are a positive, honest, and self-reflective personality with strong team skills and bring an open and quality-oriented mindset and attitude that is needed for successful work in your team and cross-departmentally. You act proactively and are characterized by your hands-on mentality. You trust yourself and others, take responsibility, and live an open speak-up and error culture. Furthermore, you have the willingness to work with a high degree of self-responsibility in an open, constructive, and collaborative environment. Your solution-oriented attitude and "can-do" mentality determine your daily actions.

As a QA Manager, you ideally have several years of professional experience in pharmaceutical production, development, or quality assurance/control. You have a successful degree in the field of pharmacy, natural sciences, or engineering, or you have a corresponding professional training combined with many years of experience in the GMP sector. Furthermore, you have thorough knowledge of the applicable GMP regulations (e.g., Eudralex Vol 4, ICH Guidelines, FDA cGMP Guidelines). You also possess the following competencies and skills:

• Quick understanding and great interest in technical processes as well as affinity in dealing with IT systems and routine use of IT systems (e.g., Google applications, as well as relevant GMP systems, e.g., SAP, Pharmasuite, Veeva).
• Great willingness and curiosity to develop flexibly and in the sense of polyvalence to learn cross-departmentally. This includes an interest in understanding, getting to know, and improving upstream and downstream process steps.
• A team-oriented mindset with a view to the constant improvement of processes and the ability to consistently deliver high-level performance in a constantly changing environment.
• Knowledge and committed use of process improvements (e.g., LPS) as well as agile management are advantageous.
• Ability and openness to recognize the opportunities and advantages of changes and to live them. In this sense, an interest in the areas of coaching and change management is advantageous.
• Proficient communication skills (in writing and verbally in German and English).

The global grade range for the position is between SE5 and SE6.

Are you ready to apply? We are looking for someone who thinks beyond the advertised position – someone who recognizes that this position can be an outstanding opportunity to shape the future of Roche.

Who We Are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.