We are currently looking for a Senior Compliance & Quality Assurance Consultant to become a permanent member of our team at ProPharma. This role involves supporting a variety of clients primarily in the Blood & Plasma therapy sector, with the flexibility to work remotely from any of our EU hubs, ideally the Netherlands, but also open to candidates from Sweden or Germany, with travel as necessary for project requirements.

The Role

As a Senior Compliance & Quality Assurance Consultant, you will serve as a key Subject Matter Expert (SME) in quality and compliance for Blood & Plasma products at both investigational and commercial stages. Your responsibilities will include providing independent consultation and project leadership for a range of complex projects in the Blood & Plasma biological space, ideally being authorized to work as a Qualified Person (QP) for tasks such as QP batch certification, GxP auditing, and developing Quality Management Systems (QMS).

Responsibilities

• Act as a Responsible Person (GDP) as needed.
• Support commercial activities from an SME perspective in Blood & Plasma QA.
• Ensure the successful execution of key projects while maintaining profitability.
• Stay updated on regulatory and technological changes in the Blood & Plasma Q&C field.
• Contribute to the implementation of risk-based and phase-appropriate GxP projects.
• Identify client needs and scope for clinical/commercial processes.
• Promote CQA services across various industry platforms.
• Enhance customer satisfaction regarding CQA consulting services.
• Provide specialized training in Blood & Plasma Q&C to clients and colleagues.
• Assist clients and all ProPharma functional units with GxP issues, including deviations and non-conformances.
• Engage with employees at all levels to foster compliance and quality assurance improvements.

Requirements

• BSc or higher in a life-sciences discipline allowing qualification as a Qualified Person.
• 10-15 years of experience in the life-sciences sector, with a strong focus on Quality Assurance.
• Proven experience with Blood or Plasma products, ideally as a Qualified Person.
• Recent active experience as a Qualified Person (QP) in the EU is highly preferred.
• Extended QA experience, including GDP activities, is preferred but not essential.
• Knowledge of manufacturing techniques for Blood and Plasma therapy products in a GMP-regulated environment.
• Familiarity with Blood & Plasma manufacturing facility qualifications and validations.
• Understanding of risk assessment tools (FMEA, FTA, HACCP, Gap Assessment, etc.).
• Auditing skills are a plus.
• Fluent in English; proficiency in any additional EU language is preferred.
• Ability to work remotely with occasional travel as required.

What We Offer

• Commitment to diversity, equity, and inclusion in the workplace.
• A supportive environment that encourages innovation and collaboration.
• Equal Opportunity Employer with a focus on creating a safe space for all employees.

We review all applications personally and ensure you receive feedback on your application status, regardless of the outcome. While remote work is supported, we encourage new hires near our offices to work in a hybrid model as agreed with their manager. All applications will be evaluated on their individual merits, and proximity to an office will not influence hiring decisions.

Please note that ProPharma Group does not accept unsolicited resumes from recruiters or third parties. No phone calls or emails regarding this posting, please.