QA Head Value Stream - Kaiseraugst, Aargau, Schweiz - F. Hoffmann-La Roche AG

Beschreibung

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Are you passionate about Quality and looking for an impactful leadership role? In this position, you will be part of the Quality organization and a member of the Kaiseraugst Site Quality Leadership Team and report to the Quality Site Head.

You will lead a team of QA Managers that partner with the production unit (Value Stream) and with support functions on site to ensure our right to operate (GMP and regulatory compliance, inspection readiness, patient safety).

Your opportunity:

• You lead respective QA function to ensure manufactured products meet company quality standards and government regulations, ensure that both global and local quality systems are in place and are constantly followed as well as ensuring compliance with national and international cGMP requirements in the area of responsibility
• You partner with respective stakeholders and business partners to ensure a constant state of inspection readiness by identifying, escalating, and working to resolve compliance risks
• You ensure close collaboration between site (including other site QA and site QS/QV groups) and Global Functions (e.g. Regulatory, Supply Chain, External Quality), foster good communication, interaction and collaboration across Value Streams, stakeholders and respective QA groups
• You notify Executive Management of significant quality or regulatory issues that may impact product quality or regulatory compliance
• You ensure oversight and trending of quality and performance KPIs. Initiate and drive a continuous improvement culture by utilizing lean and agile methodologies and efficiently use technical and organizational resources
• You support regulatory inspections and provide audit support with your team, which may include presentations and facility, utility, equipment documentation review
• You create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. You are an active and visible change agent, promoting flexible and open mindsets to new opportunities

Who you are:

• You hold a master's degree in pharmaceutical or life science, chemistry, biology, or engineering (preferably with postgraduate training or doctorate) and have minimum ten yrs of professional experience in pharmaceutical production, process validation, sterility assurance/aseptic processing, or process development
• You have a fundamental working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices (cGMPs)
• You demonstrate creative leadership skills as a Visionary, Architect, Catalyst, and Coach (VACC) by removing barriers, developing people and technical capabilities, and creating an environment for high performance
• You have organizational management expertise
• You are well known for your lean mindset and are an end-to-end thinker with a focus on continuous improvement. You implement, coach and apply Lean and agile ways of working
• You are well known for your ability to deliver at a high level in an environment that exhibits significant ambiguity
• You have outstanding communication skills, at both a global and local level, to include presenting to regulatory authorities and senior management as needed

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.