Senior Compliance & Quality Assurance Consultant

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Compliance & Quality Assurance Consultant in Germany.

This role offers a highly specialized and impactful opportunity to provide expert guidance across compliance and quality assurance for Blood & Plasma products in investigational and commercial stages. You will serve as a Qualified Person, leading projects that require deep regulatory knowledge, risk-based decision-making, and scientific expertise. Working closely with clients and internal teams, you will ensure adherence to GMP, GDP, and other regulatory standards while supporting strategic initiatives and commercial activities. The position combines independent consultancy with collaborative project execution, allowing you to influence processes, improve quality systems, and promote best practices across the EU. Travel to client sites and EU hubs may be required to deliver critical aspects of high-profile projects.

• Serve as a Subject Matter Expert in quality and compliance for Blood & Plasma products, covering GMP, GDP, and investigational/commercial processes
• Act as a Qualified Person (QP) for batch certification, quality audits, and Quality Management System (QMS) development
• Support clients and internal teams in risk-based and phase-appropriate GxP projects, deviations, and non-conformance resolutions
• Lead training sessions on Blood & Plasma Q&C, promoting regulatory awareness and continuous improvement
• Provide independent consultation on compliance and QA matters, including supporting commercial activities as an SME
• Maintain up-to-date knowledge of regulatory changes, manufacturing standards, and quality best practices
• Drive implementation and successful execution of projects while ensuring client satisfaction and profitability

Requirements:

• BSc or higher in Life Sciences or a related discipline qualifying you as a Qualified Person
• Active experience as a Qualified Person (QP) within the EU
• 10–15 years of progressive experience in life sciences, with significant focus on Quality Assurance
• Proven experience working with Blood or Plasma products, including GMP-regulated environments
• Knowledge of manufacturing techniques, facility qualifications, validations, and risk assessment tools (FMEA, HACCP, Gap Assessment)
• Experience in GDP activities and audit practices preferred
• Strong analytical, problem-solving, and organizational skills
• Excellent English communication skills; additional EU language proficiency is a plus
• Ability to work remotely while traveling to client sites or EU hubs as needed
• Ability to provide guidance across diverse teams and influence compliance practices

Benefits:

• Opportunity to lead high-impact, scientifically rewarding projects in the Blood & Plasma sector
• Work remotely from EU hubs with flexibility, while collaborating on critical project aspects
• Exposure to international clients and cross-functional teams
• Continuous professional development in regulatory compliance and quality assurance
• Contribution to industry-leading standards and best practices
• Inclusive and diverse work environment promoting innovation and collaboration