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.
