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
The Opportunity:
This role is to lead the new QMS Compliance team within Roche Pharma Technical Operations (PT) Quality & Compliance. This is a people-leader role, reporting to the Head of Audits & Compliance. Audits & Compliance establishes, maintains and executes activities to ensure alignment of the QMS with Health Authority expectation, reduce regulatory compliance risk, and drive continuous inspection readiness to ensure Roche’s License-to-operate and delivery of high-quality products to our patients.The key responsibilities of this role are:
Lead the QMS Compliance team of highly experienced individual contributors responsible for overseeing PT QMS standards to ensure they are compliant to Health Authority regulations and expectations. QMS Compliance is key to ensuring that Roche PT maintains overall adherence to Health Authority expectations
Hold accountability for the team’s core work of assessing new and evolving HA regulations and expectations and their impact on the PT QMS and the PT network, to ensure the QMS is continually in place to meet the demands of emerging regulations, industry trends, and business needs
Partner and build relationships with PT, PT Quality, and Roche Pharma global and site leaders as technical experts to ensure the success of the newly-implemented PT QMS Operating model, as well as to align on strategic priorities, accelerate decision-making, and drive continuous improvement
Provide coaching and development to ensure QMS Oversight team members have the required proficiency to execute work packages, deliver the team’s objectives and seek ways of continuously improving
Act as a strategic partner to stakeholders in PTQ and PT in support of organizational priorities
Develop annual budget and resourcing plan, revising forecasts to meet business needs and monitor/ control expenditures to ensure efficient use of company resources
Support the implementation of the PTQ strategy, ensuring it is aligned with PT and Roche Pharma priorities
Boldly advance belonging and inclusion so that people feel safe to learn, to experiment, to challenge, to contribute autonomously — and safe to be themselves
Enable talent flow across Audits & Compliance and other teams with PT/PTQ, evaluating business requirements and generating solutions for succession planning and talent management
Who you are:
You bring ten years + experience in a regulated industry, such as the pharma/bio-pharmaceutical or medical device industry with 5 years in a role with compliance ownership or oversight of global QMS documents. Furthermore:
A strong understanding of quality assurance concepts and Good Manufacturing Practices (cGMP) knowledge
Evidence of your ability to develop employees through their lateral and/or promotional movement internally or externally
Proven track records in coaching teams within a matrix environment.
Experience in multiple manufacturing technologies and product life-cycles is desirable
BA or BSc degree or equivalent in life sciences, Pharmacy or related a related scientific discipline
Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.
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.
