Background information about the job or company (e.g., role context, company overview)

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the worl...

Responsibilities or duties

As the Local Quality Responsible, you will lead and shape the strategic and operational performance of our Local Quality Management System (QMS). In this role, you will champion a robust quality culture, ensuring our clinical and pharmacovigilance activities consistently align with global standards and local regulatory requirements. You will serve as a strategic partner to leadership, driving continuous improvement and proactive risk management to deliver safe, high-quality solutions for patients.

Qualifications or requirements (e.g., education, skills)

You are a highly motivated quality professional who thrives on collaboration, strategic thinking, and continuous improvement. You possess excellent listening and decision-making skills, with a proven ability to influence teams, build consensus, and navigate challenging compliance landscapes seamlessly.

Experience needed

5+ years of professional experience within the biopharmaceutical industry or an equivalent regulated environment.

Any other provided details (e.g., benefits, work environment, team info, or additional notes)

Education: Bachelor’s degree in science, biology, or a related field (Advanced degree or specialized quality certification is preferred).

Regulatory Expertise: Demonstrated hands-on knowledge of GCP and GVP regulatory requirements, along with experience navigating Health Authority inspections or audits.

Quality & Risk Systems: Solid understanding of Quality Principles (such as ISO 9001 standards) and proactive Risk Management frameworks.

Global Collaboration: Strong verbal and written communication skills in English, with a track record of effectively managing stakeholders across a matrixed or international organization.

• Lead the Affiliate Quality Management System (QMS): Direct the operational execution of our Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality standards, ensuring compliance with local regulations.
• Champion a Culture of Quality: Partner closely with local and international leadership teams to promote compliance, manage institutional risks, and drive regular Management Review processes.
• Oversee Audit & Inspection Readiness: Act as the primary point of contact for clinical and pharmacovigilance audits and Health Authority inspections, leading local coordination and response strategies.
• Drive Continuous Improvement & CAPA: Facilitate root-cause analyses, manage the Corrective and Preventive Action (CAPA) process, and address process deviations swiftly and effectively.
• Manage Strategic Service Providers: Oversee external GCP/GVP vendors by establishing robust monitoring plans, regular risk assessments, and performance evaluations.
• Empower Through Training: Establish and maintain local training frameworks to ensure all relevant personnel are fully equipped and compliant with core global standards.

• Excellent listening and decision-making skills
• Ability to influence teams
• Ability to build consensus
• Ability to navigate challenging compliance landscapes
• Strong verbal and written communication skills in English
• Effective stakeholder management

• Bachelor’s degree in science, biology, or a related field (Advanced degree or specialized quality certification is preferred).
• 5+ years of professional experience within the biopharmaceutical industry or an equivalent regulated environment.
• Demonstrated hands-on knowledge of GCP and GVP regulatory requirements
• Experience navigating Health Authority inspections or audits
• Solid understanding of Quality Principles (such as ISO 9001 standards)
• Solid understanding of proactive Risk Management frameworks