Lead Compliance Specialist

Johnson & Johnson is currently seeking a Lead Compliance Specialist to join our Compliance Team located in Issy-les-Moulineaux, France.

1 day a week office presence is required.

Position Summary

This position is responsible for performing activities within the assigned portfolio (e.g. process(es); primarily for GCO, but may include support for other functional, department(s), where relevant) that (1) ensure an integrated and comprehensive compliance approach for clinical trials in close collaboration with local and global functions (e.g. Quality, Privacy, HCC, Legal, Global/Local Medical Safety, and Operations), and (2) ensure clinical trials are performed in compliance with relevant laws and regulations, industry standards and Johnson & Johnson processes and procedures.

Principal Responsibilities

• Compliance Oversight: Monitor compliance risk and ensure mitigation/remediation actions are defined.
• Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner.
• Conduct Compliance Monitoring Visits.
• Perform relevant reviews, such as Trial Master File, training compliance documentation and other checks per the defined strategy.
• Planning and execution of compliance checks.
• Supporting and advising teams in root cause analysis of significant observations.
• Ensuring appropriate filing of compliance documentation.
• Support Quality Reviews with GCO management to address compliance issues and risk signals.
• Collaborate with business partners to facilitate inspections and audits as needed.
• Collaborate with business partners in timely CAPA setting and implementation; provide CAPA Champion support.
• Support impact assessment of global procedural documents and, if applicable, support development and management of associated procedural documents.

Onboarding and Consultation

• Support onboarding of new hires.
• Manage workshops to support QMS and compliance awareness, Lessons Learned, etc.
• Provide advice regarding SOP, system and GCP questions of moderate complexity.
• Supports managing risk, including assessing root causes and developing effective actions to mitigate risk.

Regulatory intelligence

• Perform impact assessments of new/revised regulations, guidance, and standards.
• Support central functions in ensuring intelligence is up-to-date.

Collaboration with Key Functions

• Support Management Review in collaboration with key partners (e.g. Quality, Privacy, HCC, Legal, and Operations).
• Support supplier assessments, as appropriate.
• Support annual requirements, including Due Diligence updates, reporting, certification, and training (e.g. of suppliers), if applicable.

Education and Experience Requirements

• A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 5-6 years relevant experience equivalent is required.
• A minimum of 4 years of previous Pharmaceutical Industry experience is required, with at least 3 years of GxP experience within clinical research and development and/or quality assurance.
• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
• Knowledge of the overall drug development process.
• Developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities).
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions.
• Ability to translate data into information and strategies into executable action plans improving the business.
• Ability to motivate professional colleagues and stakeholders.
• Conflict resolution/management and negotiation skills.
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
• Experience of the key customers’ business processes and practices.
• Good working 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
• Good conflict handling/negotiation skills
• Able to create win-win situations with internal and external partners
• Knowledge of corporate structure and culture

Impact – Complexity and Scope

Contributes to the definition and development of new processes, standards, or operational plans in support of the organizational/business strategies, with a direct impact on business unit/function overall results. Typically has responsibility for smaller scope projects. Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects. Contributes to local and regional strategy.

Nature of Communication

Influences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, approaches, and concepts.

Innovation

Identifies issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope.

Excellent knowledge of English and French is required.

Required Skills

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).

The anticipated base pay range for this position is: €53,500.00 - €85,790.00.

Benefits

• Annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health.
• Service anniversary and recognition awards.
• Eligible dependents may participate in several insurance plans (subject to the terms of their respective plans).

EEO Statement

We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.