Senior Quality Lead

Roche seeks a Senior Quality Lead in Basel, CH, for a full-time hybrid role within Pharma Development Quality. The position focuses on ensuring data and process integrity, leading audits and regulatory inspections, and driving quality strategy across GCP, GVP, and Medical Device domains.

This role is part of Pharma Development Quality (PDQ), dedicated to ensuring data and process integrity, agility, and transparency with health authorities, patients, and society. The Senior Quality Lead will shape quality strategies and support regulatory compliance across drug development and medical device areas.

Responsibilities

• Develop and execute quality assurance strategies by collaborating with business stakeholders, evaluating risks, and applying the Critical to Quality (CtQ) framework across GCP, GVP, and Medical Device domains.
• Plan and oversee audits, determine necessary audit scopes, use data analytics to create methodologies, and manage the full audit lifecycle from planning to reporting.
• Oversee quality issues, monitor recurring findings to improve processes, and escalate critical risks to PDQ leadership.
• Assess quality positions to guide compliance actions, lead high-level risk discussions, and participate in strategic conversations with business units, Pharma, Legal, and Regulatory Affairs.
• Lead preparation, training, and management of major regulatory inspections (e.g., FDA, EMA), and confidently present quality strategies and outcomes.
• Contribute to PDQ’s long-term strategy, lead compliance initiatives, and mentor other Quality Leads in the team.

Requirements

• Deep experience in drug development and clinical trials, with cross-functional exposure in GCP, GVP/PV, or Medical Devices/SaMD.
• Demonstrated success in leading major health authority inspections (e.g., FDA, EMA), including readiness and post-inspection follow-up.
• Strong problem-solving abilities with a proactive, risk-based approach and experience using data and data visualisation tools to inform decisions.
• Excellent relationship-building skills, with a history of influencing senior stakeholders and negotiating effective solutions.
• Experience managing global, multicultural projects and a commitment to coaching and mentoring team members.
• Bachelor’s degree or equivalent in a scientific or quality-related discipline.

Nice to have

• Advanced degree in a scientific or quality-related field.

What the company offers

• Opportunity to work in a collaborative, inclusive environment that encourages personal expression and open dialogue.
• Chance to contribute to Roche’s mission of advancing science and ensuring healthcare access for everyone.

About the company

Roche promotes a culture of personal expression, open dialogue, and meaningful connections, where employees are valued and respected. The company is committed to advancing science and ensuring healthcare access for all, guided by scientific rigour, creativity, inclusive teamwork, and exceptional delivery.

• Encourages personal expression and open dialogue among employees.
• Driven by a mission to advance science and ensure healthcare access for everyone.
• Values scientific rigour, creativity, inclusive teamwork, and exceptional delivery.