Compliance Specialist

Description

• Supporting regulatory authority inspections and external audits by preparing documentation, coordinating responses, and following up on observations
• Managing and tracking CAPA plans, ensuring actions are implemented on time and effectiveness is verified
• Supporting continuous inspection readiness by reviewing compliance status and addressing gaps proactively
• Planning, coordinating, and participating in scheduled or event driven internal compliance audits
• Reviewing quality performance metrics and helping to develop and track corrective and improvement action plans
• Monitoring regulatory updates and quality system changes and communicating relevant information to management
• Supporting global compliance knowledge management and maintaining compliance related documentation
• Working closely with internal sites and external GMP suppliers on compliance topics and quality requirements
• Supporting vendor audits, Quality Technical Agreements (QTAs), deviation investigations, and change control activities
• Reviewing, maintaining, and updating the Site Master File as required

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or a related scientific discipline
• Minimum 2-year experience working in Quality Assurance, Compliance, or Regulatory roles within a GMP regulated environment
• Ability to simplify processes, identify bottlenecks and translate stakeholder feedback into clear processes
• Active listener and decision-making skills
• Team role player with strong analytical and critical thinking approach
• Knowledge of OPEX and implementation of time management tools (i.e. Daily Tier meetings, workplan boards)
• Hands on experience supporting regulatory authority inspections and external or internal audits
• Practical knowledge of CAPA management, including investigation follow up and effectiveness checks
• Good understanding of GMP principles, quality systems, and regulatory requirements (e.g., EMA, FDA, ICH)
• Experience working with suppliers or vendors, including audits, deviation investigations, or change controls
• Familiarity with Quality Technical Agreements (QTAs) and Site Master File maintenance is an advantage
• Ability to review quality performance data and support development of improvement action plans
• Strong documentation, organizational, and communication skills
• Ability to work independently, manage multiple priorities, and collaborate effectively with cross functional and global teams
• Ability to work independently while collaborating effectively with cross functional teams
• Fluent verbal and written communication skills in English