QA Manager - Quality Control (2 years term) — Roche

Full description

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 As part of the Quality Assurance for Quality Control (QAfQC), you act as a central expert for all quality-relevant QC issues. The Quality Unit consists of Quality Assurance, Quality Control, Quality Systems and Quality Compliance and Issues. We guarantee the quality and compliance of over 40 product families for more than 120 countries in one integrated drug product and packaging site. In addition, we are responsible for the centralized QC and the release and stability testing of sterile and non-sterile products as well as raw materials and packaging materials.

Our philosophy is that quality is the right of every patient, that we take responsibility for it and do our part.

The possibility As QA Manager, together with your colleagues within the QA team, you are responsible for ensuring that our products meet the specific requirements and that the analytics and approvals comply with both legal compliance in the customer markets and the internal Roche Pharma Quality Standard (PQS) requirements. You are an expert for all quality-relevant questions and the link between quality control and other relevant interfaces.

• Ensuring quality oversight in the QC by, inter alia, conducting QA visits and participating in and supporting self-inspections and audits of authorities
• Review and approval of qualification and validation reports in the field of laboratory equipment, plants and CSV.
• QA responsibility as well as processing of deviations, CAPAs and changes as well as other GMP documents.
• Introducing and implementing ideas to improve the quality and efficiency of processes and reduce costs. Improvements using Lean Production System (LPS) - advancing methods and tools and living in daily business.
• Close cooperation with internal and external interfaces to achieve our ambitious goals of quality, lead time, commitment and cost.
• Incorporation and assumption of new activities in neighbouring areas in the sense of a polyvalent further 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 thinking, integrity and self-reflective personality with strong team skills and bring an open and quality-oriented attitude and mindset that is needed for successful work in your team and across departments. You act proactively and distinguish yourself through 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 personal responsibility in an open, constructive and collaborative environment. Your solution-oriented attitude and “can-do” attitude determines your daily actions. As a QA Manager Ideally, you have several years of professional experience in pharmaceutical production, development or quality assurance/control. You have successfully completed studies in the field of pharmacy, natural sciences, engineering or have an appropriate professional training, combined with many years of professional experience in the GMP field. Furthermore, you have in-depth knowledge of the valid GMP regulations (e.g. Eudralex Vol 4, ICH Guidelines, FDA cGMP Guidelines).

You also have the following competencies and skills

• Quick comprehension and great interest in technical processes as well as affinity in dealing with IT systems and routine handling of IT systems (e.g. Google/Microsoft applications and relevant GMP systems).
• Great willingness and curiosity to develop flexibly and to learn cross-divisionally in the sense of polyvalence. This includes an interest in capturing, getting to know and improving upstream and downstream process steps.
• A team-oriented mindset with a view to constantly improving processes and the ability to deliver consistent performance at a high level in an ever-changing environment.
• Knowledge and convinced commitment to process improvements (e.g. LPS) as well as Agile Management are beneficial.
• Ability and openness to recognize and live the opportunities and benefits of change. In this sense, an interest in the areas of coaching and change management is beneficial.
• Strong communication skills in word and writing in German and English.

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.

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