Lead Compliance Specialist

Lead Compliance Specialist – Issy-les-Moulineaux, France

Johnson & Johnson’s Compliance Team seeks a Lead Compliance Specialist to support clinical trial compliance across multiple functions in Issy-les-Moulineaux, France. One day a week office presence is required.

Position Summary

This position is responsible for performing activities within the assigned portfolio (primarily for Global Clinical Operations, with possible support for other functions) that ensure an integrated and comprehensive compliance approach for clinical trials. The role collaborates with local and global functions such as Quality, Privacy, Health Canada, Legal, Medical Safety, and Operations to ensure trials are conducted in compliance with applicable laws, regulations, industry standards and J&J processes.

Principal Responsibilities

• Monitor compliance risk and define mitigation or remediation actions.
• Monitor progress and confirm effectiveness of remediation plans, including performing QC checks or special investigations, and reporting results.
• Conduct compliance monitoring visits, and perform reviews of Trial Master File, training documents, and other checks per the defined strategy.
• Plan and execute compliance checks and support root‑cause analysis of significant findings.
• Ensure appropriate filing of compliance documentation.
• Support quality reviews with GCO management to address compliance issues and risk signals.
• Collaborate with partners to facilitate inspections and audits, CAPA setting and implementation, and impact assessment of global procedural documents.
• Provide advice on SOP, system and GCP questions of moderate complexity.
• Perform impact assessment of new or revised regulations, guidance and standards.
• Support preparation of supplier assessments, due‑diligence updates, reporting, certification and training.

Education and Experience Requirements

• Minimum of a Bachelor’s degree in Science or Arts, or 5‑6 years of relevant experience; at least 4 years of prior pharmaceutical industry experience.
• Minimum of 3 years of GxP experience within clinical research, development or quality assurance.
• Demonstrated AI literacy and ability to use AI tools responsibly to improve productivity and quality.
• Knowledge of the overall drug development process and SOPs governing clinical research activities.
• Experience in quality assurance activities, including audits of clinical investigative sites, systems, vendors and regulatory submissions.
• Ability to translate data into information and strategies into executable action plans that improve business outcomes.
• Ability to motivate colleagues and stakeholders, manage conflict and negotiate effectively.
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
• Knowledge of FDA, ICH and country‑specific regulations and guidelines related to clinical development.
• Experience with regulatory submissions (NDA, BLA) is an asset.

General Skills

• Problem solver
• Collaborator
• Highly committed to quality and compliance
• Flexible and persistent
• Conflict handling / negotiation skills
• Ability to create win‑win situations with internal and external partners
• Knowledge of corporate structure and culture

Required Skills

• Analytical Reasoning
• Clinical Research and Regulations
• Clinical Trial Designs
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Communication
• Data Savvy
• Laboratory Operations
• Organizing
• Problem Solving
• Productivity Planning
• Professional Ethics
• Project Integration Management
• Quality Assurance (QA)
• Regulatory Compliance
• Research and Development
• Research Ethics
• Standard Operating Procedure (SOP)

Preferred Skills

• Analytical Reasoning
• Clinical Research and Regulations
• Clinical Trial Designs
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Communication
• Data Savvy
• Laboratory Operations
• Organizing
• Problem Solving
• Productivity Planning
• Professional Ethics
• Project Integration Management
• Quality Assurance (QA)
• Regulatory Compliance
• Research and Development
• Research Ethics
• Standard Operating Procedure (SOP)

Compensation

€53,500.00 - €85,790.00 per annum.

Benefits

In addition to base pay, benefits include an annual bonus, vacation days, parental leave (minimum 12 weeks), bereavement, caregiver, volunteer leave, well‑being reimbursement and various insurance plans. Additional benefits may vary by location and are subject to change.