Head of Quality Process Management
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
PTQ ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche.
The Head of Quality Process Management will be accountable for the strategic design, maintenance and ongoing compliance of Quality owned Processes such as APQR, Complaints, Deviations and CAPAs. It supports the translation of `in place` requirements into `in use` and designs concepts and metrics for the `in control` performance.Driving efficiencies and automation in these areas. This includes ensuring that processes are harmonized, simplified and data collection is automated where possible to increase data quality and allow for better data insights. This will be a key pillar for PTQ driving for more proactive compliance and effectiveness.
Lead a global team of 40 individuals consisting of SMEs, technical Quality process experts supporting and executing Quality processes and respective deliverables.
The Opportunity:
You define, establish, and maintain robust Quality-owned processes across Roche’s Quality, Compliance, and Pharma Technical (PT) network. This includes ensuring that all processes are designed for regulatory compliance, operational efficiency, and ease of execution. Furthermore you:
- Lead initiatives to streamline and simplify quality processes, removing unnecessary complexity while maintaining the highest standards of compliance and control
- Design frameworks that ensure real-time visibility into process execution through actionable metrics and dashboards, enabling early identification of gaps and proactive implementation of corrective measures
- Champion the automation of Quality processes by leveraging digital tools and platforms to reduce manual interventions, improve data integrity, and enhance process consistency
- Drive a culture of compliance excellence and continuous improvement by embedding LEAN principles into the design, execution, and evolution of quality processes
- Collaborate closely with Business Process Lifecycle and Integration teams, as well as Quality Systems & Standards, to ensure seamless integration of Quality Management System (QMS) improvements and evolving regulatory requirements into Roche’s digital ecosystem (e.g., ERP, Veeva, BRH)
- Work in close partnership with stakeholders across manufacturing sites, External Quality (ExQ), and Development to ensure efficient, consistent, and sustainable execution of Quality processes
- Share accountability with cross-functional partners to optimize quality operations and ensure strategic alignment with Roche’s quality vision and also provide expert services, tools, and guidance to build organizational capability in quality process management, fostering a proactive and innovation-driven culture
- Leverage technical expertise to support scalable, automated data availability solutions that enable a “one-click” data access model, feeding into Roche’s Management Review of Quality (MRoQ) oversight framework and act as a key enabler for transparent, real-time decision-making by ensuring that quality data is accurate, reliable, and readily accessible across the organization
Who you are:
You have a Bachelor's degree with 15 years, Master's degree with 13 years, or PhD with 10 years of proven experience in the pharmaceutical industry, preferably in Chemistry, Chemical Engineering, or related sciences. Furthermore:
- Extensive leadership experience in quality within the pharmaceutical/biotechnology industry, ideally in global and site roles
- People leader and developer in a multicultural environment and virtual set-up, with demonstrated ability to lead business and people through high impact change and transformation
- Deep understanding and knowledge of quality processes
- Inclusive leader that gets things implemented with a passion for data insights and an inspiring approach towards organizational usage of data
If you are ready to join an exciting and ambitious environment where science and patient health is your purpose, please submit your application.
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.