Qualification Lead

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.

For a successful production site Kaiseraugst Engineering & SHE enables GMP-readiness equipment and utilities. Our key success factors for sustainable and compliant asset performance are continuous improvement of our processes, agile employees and passion

As Qualification Lead, you lead, manage and execute PTM Kau qualification activities and projects, develop sound qualification concepts and strategies and ensure maintaining the qualified status of all assets over their entire lifecycle.

As Qualification Lead you develop sound concepts/strategy for qualification based on the applicable requirements, regulatory specifications and ensure maintaining the qualified status of all assets over their entire lifecycle in close collaboration with the global functions. You coordinate and manage qualification projects and act as matrix lead and coach for your colleagues in local and global projects in strong collaboration with the Manufacturing Units, MSAT and Quality to implement qualification lifecycle requirements into new technology. You coordinate and monitor qualification projects and ensure the know-how transfer between the individual projects and qualification tasks enabling systemic learning and continuous improvement of the qualification process.

• You initiate and execute qualification risk assessments, author qualification documentation (QMP, QPPs, QSR, test protocols, SOPs, rationales etc) and review technical documentation

• You are also responsible for the coordination of external qualifiers (purchasing coordination, training organization, training concept) and supervision of scientific theses.

• In health authority inspections and audits you represent the E2E qualification strategy, plans, reports and status (including preparation, presentation, support, and follow-up)

• Ensuring an excellent  flow of information with all stakeholders (e.g. Value streams, Eng&SHE, Manufacturing Units, PS, PTQ, PTT, PTM, PTD, other functions, suppliers etc.)

• Ownership and execution of complex qualification changes (PE, CAPA) and deviations (UPE, Investigations) as well as Qualification Impact Assessments (PQR) and supporting complex troubleshooting is part of your daily business

• Promoting methods and tools together with the LPS team and living in day-to-day business. Introducing ideas to improve quality, plant efficiency, cost reduction and processes.

You are a positive-thinking, honest and self-reflective personality with strong communication skills. You have an open ear for the daily challenges of your colleagues and create a climate of mutual support. You act as a team player, listen actively and provide sufficient space for others to express their ideas. You ask questions to understand, speak openly and honestly on controversial issues.

You have a master degree in Process / chemical engineering, biotechnology, chemistry, mechanical engineering or a comparable qualification(preferably with postgraduate training or doctorate) and minimum 3 years of professional experience in pharmaceutical production, qualification, engineering or validation. You have deep knowledge and in-depth knowledge of production processes, pharmaceutical or process engineering (e.g. filling techniques, lyophilization, filtration) and/or packaging technology.

• Specialized knowledge in the area of ​​qualification as a local and global subject matter expert and good knowledge of relevant health authority requirements and experiences in executing registration relevant technical changes

• Ability to consistently perform at a high level in a constantly changing environment as well as proven successful delivery of cross functional projects and expertise in stakeholder management and in conceptual planning with a proven ability to reduce complexity

• Ability to effectively communicate and influence others across all levels of the organization with fluent verbal and written communication skills in German and English

• A fundamental, working understanding of safety, quality systems, and quality assurance concepts are required including the application of current Good Manufacturing Practices (cGMPs)

• Track record of having the courage to drive change, while balancing risks and pacing for success with the ability and openness to recognize and live the opportunities and advantages of change

• Ideally experience in dealing with digitization of processes (Valgenesis, etc)

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.