Local Quality Responsible

About Roche

Roche fosters an environment where people can bring their authentic selves to work. The company values openness, respectful exchange, individuality, and meaningful connection, with the goal of advancing healthcare for current and future generations.

Its mission is to help prevent, stop, and cure diseases while improving access to healthcare worldwide.

The Role

As the Local Quality Responsible, you will own the strategic and day-to-day performance of the local Quality Management System (QMS). You will strengthen a strong quality mindset across the affiliate and ensure that clinical and pharmacovigilance operations are aligned with both global expectations and country-specific regulations. In this position, you will act as a trusted partner to leadership, support continuous improvement, and help manage risk so patients receive safe, high-quality outcomes.

Core Responsibilities

• Steer the affiliate QMS and ensure the operational delivery of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) standards in line with local regulatory obligations.
• Work with local and global leaders to build a quality-focused culture, support compliance, manage institutional risks, and run regular management review activities.
• Serve as the main contact for clinical and pharmacovigilance audits as well as Health Authority inspections, coordinating local preparation and responses.
• Lead root-cause investigations, oversee the Corrective and Preventive Action (CAPA) process, and address deviations promptly and effectively.
• Manage external GCP/GVP service providers by setting monitoring approaches, performing risk reviews, and tracking supplier performance.
• Create and sustain local training systems so relevant teams remain trained, compliant, and aligned with global standards.

Profile Required

• You are a driven quality professional who works well in collaborative environments and enjoys strategic problem-solving and ongoing improvement.
• You should have strong listening and decision-making abilities, along with the confidence to influence others, gain alignment, and handle complex compliance situations.
• A bachelor’s degree in science, biology, or a related discipline is required; an advanced degree or a quality-related certification is an advantage.
• At least 5 years of professional experience in the biopharmaceutical industry or another regulated environment is expected.
• Practical knowledge of GCP and GVP requirements is essential, along with experience supporting audits or Health Authority inspections.
• You should understand quality frameworks such as ISO 9001 and be familiar with risk management practices.
• Strong English communication skills, both written and spoken, are needed, especially for working with stakeholders in a matrixed or international setting.

Additional Information

The full job description can be shared on request.

Who We Are

Roche is powered by more than 100,000 employees around the world who work to advance science and improve access to healthcare. The company’s work has supported more than 26 million people through its medicines and over 30 billion diagnostic tests globally. Roche encourages creativity, high ambition, and shared purpose to deliver healthcare solutions with global impact.

Roche is an equal opportunity employer.