The Position

With its 1,400 employees, the Kaiseraugst production center (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and serving more than 120 countries.

For a successful production site Kaiseraugst Engineering Science and Technology (ES&T) advances and enables innovation and improvement by using science, technical knowledge and predictive services. 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.

Your area of responsibilities

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 PLaNTs Organization, Value Streams and ES&T Process Owners 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.

In addition:

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, ES&T, PLaNTs, 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 (RTPQR) 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.

Who you are

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.

Your Qualifications/Requirements:

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.

In addition you have

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)

Do you have any questions? Please check our FAQs and videos on careers.roche.ch/faq.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.