GCP Compliance Director: Global Quality & Trials Leader

Novartis; Barcelona; Hybrid; EUR 85,000 - 158,000; Full time

Benefits offered by this job

Hybrid work options

14 weeks parental leave

Insurance & retirement plans

Job summary

Novartis in Barcelona seeks a GCP Compliance Director (Program & Study) to lead global clinical quality and regulatory compliance efforts. You will manage a team of GCP Compliance Managers, drive inspection readiness, and ensure alignment with GCP, regulatory requirements, and internal standards.

You will influence portfolio delivery, foster a culture of trust and continuous improvement, and collaborate with Development Units, Quality, and cross-functional teams.

Qualifications

• Advanced degree in Life Sciences or related field.
• Significant pharma/biotech or CRO experience in clinical research.
• Proven record of leading global, matrixed teams.
• Extensive knowledge of GCP, international standards and regulations.
• Ability to translate quality insights into business decisions.
• Experience influencing senior leaders and cross-functional partners.

Responsibilities

• Provide compliance oversight across Global Clinical Operations and development portfolios.
• Lead and develop a team of GCP Compliance Managers.
• Drive program and trial compliance with GCP and regulatory requirements.
• Oversee audits, inspections, quality events, and CAPA activities.
• Ensure proactive risk assessment and escalation of quality issues.
• Lead inspection readiness activities and corrective action plans.
• Communicate trends and insights to Develop Unit leadership and stakeholders.
• Support evolution of GCP compliance frameworks and operating models.

Skills

Leadership

GCP Compliance

Audit & Inspection

Regulatory Knowledge

Strategic Thinking

Education

Advanced life sciences degree

Job description

Novartis in Barcelona seeks a GCP Compliance Director (Program & Study) to lead global clinical quality and regulatory compliance efforts. You will manage a team of GCP Compliance Managers, drive inspection readiness, and ensure alignment with GCP, regulatory requirements, and internal standards.

You will influence portfolio delivery, foster a culture of trust and continuous improvement, and collaborate with Development Units, Quality, and cross-functional teams.