Senior Quality Lead

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

At Roche we advance science so that we all have more time with the people we 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.

The Opportunity

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 Bachelors degree or equivalent in a scientific or quality-related field (an advanced degree is preferred).

Location

• This position must be based in either Basel Switzerland. Although this can be a hybrid role with an expectation of ongoing and sustained site presence in compliance with local company site requirements

• International business travel may be required. Typically this will be required about 10% of the time depending on the roles requirements.

#MQRS

Relocation benefits are not available for this position

Scientific rigour and creativity inclusive teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together we can be transformative.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.