Director, Clinical Quality Evaluation and Inspection Intelligence

This is a fully remote position, open to applicants in Sweden, +2 more countries.

📋 Description

• Design and enhance the GCP quality oversight and audit framework to facilitate risk-appropriate CMQ supervision of clinical trials.

• Ensure the prompt implementation of the GCP audit program and quality assessments of GCP service providers; may serve as the Lead Auditor for designated audits.

• Drive modernization and data analytics projects within CMQ to implement solutions that foster quality innovation.

• Establish and manage the inspectional intelligence framework for clinical study operations, encompassing signal detection, trend analysis, and insight-to-action workflows.

• Participate in risk-management efforts for GCP processes, computerized systems, and studies.

• Collaborate with function and study leaders on continuous GCP inspection readiness, coordination, and follow-up activities.

• Function as the QA approver for audit reports, serious noncompliance investigations, high-risk CAPAs, and selected procedural documents.

• Serve as the CMQ lead for one or more complex studies.

• Represent CMQ on various internal and external governance boards.

• Lead a team of CMQ managers.

⛳️ Requirements

• MSc or PhD in pharmacology, healthcare, or another relevant life science field.

• Possession of GCP Auditor qualification credentials from a recognized international organization, such as SQA RQAP-GCP, EFGCP, etc.; ACRP-CP or CCRA/CCRC certifications are preferred.

• At least 10 years of combined experience in GCP-governed operational and audit roles involving multi-centric international clinical trials within biopharmaceutical companies or CROs.

• Experience in oncology and immunology is required; experience in ophthalmology and neurology is a plus.

• Minimum of 5 years of substantial exposure to GCP inspections conducted by FDA, EU Member States authorities, and PMDA; MHRA / ANVISA inspection experience is desirable.

• At least 5 years of experience conducting GCP audits for clinical investigator sites, GCP service providers, eTMF, and other computer systems/digital health technologies used in clinical studies.

• Strong digital proficiency with experience in Veeva Clinical and Quality Vaults.

• Background in process optimization and integration with digital tools.

• Experience with AI/ML is highly preferred.

• Proven experience in leading decentralized teams.

• Exceptional communication, writing, and presentation skills in English and at least one other official EU/EEA/RS language.

• Demonstrated comprehensive understanding of regulatory procedures for biological medicine authorization in the EU and USA, as well as ICH and EMA guidelines governing clinical trials.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.

• A collaborative and inclusive work environment.