Local Quality Responsible

Local Quality Responsible

Job Overview

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.

Key Responsibilities

• 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.

Who You Are

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.

Qualifications & Experience

• Education: Bachelor’s degree in science, biology, or a related field (Advanced degree or specialized quality certification is preferred).
• Experience: 5+ years of professional experience within the biopharmaceutical industry or an equivalent regulated environment.
• 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.