Clinical FSP Quality Manager – GCP Compliance & Risk

IQVIA; Madrid; On-site; EUR 90,000 - 120,000; Full time

Job summary

IQVIA in Madrid seeks an experienced QA professional to lead quality management activities within designated Delivery Units and cross-functional teams. You will define and implement the global Quality Plan and support compliance with GCP, ICH, SOPs and regulatory requirements.

The role requires deep knowledge of clinical development processes, 8+ years of experience, and fluency in English. You will partner with staff and stakeholders to maintain high quality across project delivery and audits.

Qualifications

• Minimum 8 years of experience in clinical trial design, planning, start up, conduct, analysis and reporting.
• Knowledge of national and international regulations and drug development processes.
• Knowledge of CRO or pharmaceutical industry operations.
• Fluent in English.

Responsibilities

• Adopt and implement the global Quality Management Plan within the scope of the assignment.
• Cooperate closely with stakeholders to focus on quality in project delivery.
• Develop and implement a Delivery Unit/ Sponsor Quality Management plan and Risk Management Program.
• Provide advice on GCP compliance to teams.
• Manage non-compliance and quality issues per SOPs.
• Inform Quality Management and stakeholders of quality issues per SOPs.
• Collaborate with Quality Assurance during audits and inspections as needed.
• Act as primary QA contact for quality matters and attend meetings.
• Prepare periodic quality risk and improvement reports.

Skills

Problem solving

English fluency

Relationship building

Job description

IQVIA in Madrid seeks an experienced QA professional to lead quality management activities within designated Delivery Units and cross-functional teams. You will define and implement the global Quality Plan and support compliance with GCP, ICH, SOPs and regulatory requirements.

The role requires deep knowledge of clinical development processes, 8+ years of experience, and fluency in English. You will partner with staff and stakeholders to maintain high quality across project delivery and audits.