Senior Clinical FSP Quality Lead

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

Job summary

IQVIA is a leading global provider of clinical research services, insights and healthcare intelligence. We are seeking a seasoned Quality Management professional for delivery units in Spain to drive the global Quality Plan and ensure GCP and SOP compliance across clinical development programs.

The successful candidate will work with regional and global teams, monitor quality, lead risk assessments, and implement corrective actions while supporting audits and inspections as required.

Qualifications

• Minimum 8 years in clinical trial design, planning, start-up, conduct, analysis and reporting.
• Strong knowledge of national and international regulations and drug development.
• Experience in CRO or pharmaceutical industry operations.
• Excellent problem-solving and stakeholder management.

Responsibilities

• Adopt and implement the global Quality Management Plan within the scope of the assignment.
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to SOPs.
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.
• Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.

Skills

Clinical trial design

GCP compliance

Quality management

Regulatory knowledge

Fluent in English

Job description

IQVIA is a leading global provider of clinical research services, insights and healthcare intelligence. We are seeking a seasoned Quality Management professional for delivery units in Spain to drive the global Quality Plan and ensure GCP and SOP compliance across clinical development programs.

The successful candidate will work with regional and global teams, monitor quality, lead risk assessments, and implement corrective actions while supporting audits and inspections as required.