Remote Clinical Quality Lead — FSP & Compliance

IQVIA; Stockholms kommun; Hybrid; SEK 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Remote work

Global collaboration

Job summary

IQVIA is seeking an experienced quality and compliance professional for a fully remote (home-based) role based in Sweden. You will partner with global and regional Quality Management teams to define and implement the global Quality Plan, drive risk management, CAPAs, and support inspections and audits.

The role requires strong knowledge of GCP, ICH, SOPs, and regulatory requirements, with 9+ years of Clinical Operations experience and oncology exposure preferred. Fluency in English is essential.

Qualifications

• 9+ years total experience in Clinical Operations.
• Clinical Operations background with GCP/compliance experience.
• Strong site oversight and risk management.
• Oncology experience preferred.
• Bachelor's Degree or equivalent qualification.
• Solid knowledge of ICH, GCP, SOPs and regulatory requirements.

Responsibilities

• Conduct country and site-level compliance oversight using a risk-based approach.
• Identify compliance risks, conduct site assessments, and manage CAPAs.
• Support inspections and audits while serving as the local GCP expert.
• Drive inspection readiness and compliance at the country level.
• Adopt and implement the global Quality Management Plan within the scope of assignment.
• Cooperate with stakeholders to maintain focus on quality in project delivery.
• Provide advice on GCP compliance to teams and staff.
• Prepare periodic quality reports and risk assessments.

Skills

Quality management

GCP compliance

Audits & inspections

English language

Microsoft Office

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

IQVIA is seeking an experienced quality and compliance professional for a fully remote (home-based) role based in Sweden. You will partner with global and regional Quality Management teams to define and implement the global Quality Plan, drive risk management, CAPAs, and support inspections and audits.

The role requires strong knowledge of GCP, ICH, SOPs, and regulatory requirements, with 9+ years of Clinical Operations experience and oncology exposure preferred. Fluency in English is essential.