Senior Quality Lead
Roche
Basel, Basel-Stadt, Schweiz/Suisse/Svizzera/Svizra
Full-Time
Competitive
OfficeManager
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 Opportunity
At Roche, we advance science so that we all have more time with the people we love. In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivalled transparency with health authorities, patients, and society. As a Senior Quality Lead within our Quality Assurance Process and Affiliate team, you will bring diverse thinking and technical expertise across various quality disciplines to support the Roche/Genentech organisation.
In this pivotal role, you will design and deliver risk-based Quality Assurance strategies, audits, and conclusions for post-approval products, affiliates, and processes. You will act as a trusted partner to senior business stakeholders, guiding cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.
Design and Implement QA Strategies: Partner with business stakeholders to independently define the QA approach, assessing risks and adapting strategies using the Critical to Quality (CtQ) framework across GCP, GVP, and Medical Device areas.
Define and Lead Audits:Determine required audits, leverage data analytics to develop methodologies, and independently manage the end-to-end audit process from preparation to reporting.
Manage Quality Issues:Independently manage quality issues, tracking systematic findings for process improvement and escalating significant risks to PDQ management.
Quality Conclusion and Stakeholder Communication: Independently evaluate quality positions to drive compliance action plans. Lead high-level risk presentations and strategic discussions with business stakeholders, Pharma representatives, Legal, and Regulatory Affairs.
Lead and support Health Authority Inspections: Lead preparation, staff training, and the management of major regulatory inspections (e.g., FDA, EMA), confidently presenting quality strategies and conclusions.
Drive PDQ Leadership & Mentorship: Contribute to the long-term strategic direction of PDQ, lead compliance projects, and act as a dedicated mentor to develop Quality Leads within the team.
Who You Are
You are a proactive, strategic thinker who thrives in a collaborative, matrixed environment and is passionate about driving Quality outcomes. You possess strong digital and data literacy, allowing you to turn data into insights, and you are comfortable asking challenging questions to support PDQ outcomes.
To be successful in this role, you bring:
Extensive Quality Expertise: A strong background in the drug development process and clinical trials, with robust cross-functional experience in GCP, GVP/PV, or Medical Devices/SaMD.
Inspection Leadership: A proven track record of leading major Health Authority inspections (such as FDA or EMA), including inspection readiness and post-inspection management.
Analytical & Critical Thinking: Advanced problem-solving skills with a proactive, risk-based mindset and the ability to utilise data and data visualisation tools to drive decisions.
Influencing & Communication Skills: Exceptional relationship management skills with a proven ability to negotiate effective solutions and influence senior stakeholders.
Inclusive Leadership:Experience managing projects in global, multicultural teams, with a passion for coaching and mentoring others.
Academic Qualifications: A Bachelor’s degree or equivalent in a scientific or quality-related field (an advanced degree is preferred).
Location
This position is based in Welwyn, Basel, SSF or Mississauga.
Relocation Assistance is not available.
#MQRS
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.