Senior Compliance & Quality Assurance Consultant (Blood & Plasma)

Location: Remote from EU hubs, ideally the Netherlands; Sweden or Germany are also possible. Travel is required when critical project activities demand it.

Company

Provides regulatory, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology consulting for biotech, medical device, and pharmaceutical organizations.

What you will do

• Serve as a subject matter expert in quality and compliance for investigational and commercial Blood & Plasma products.
• Provide independent consultation to clients and project leaders across complex biological product projects.
• Perform Qualified Person activities, including batch certification, GxP auditing, and quality management system development.
• Act as a Responsible Person for GDP activities when required.
• Support risk-based, phase-appropriate GxP projects, including deviations, non-conformances, and continuous improvement.
• Deliver Blood & Plasma quality and compliance training and support commercial activities as a subject matter expert.

Requirements

• BSc or higher in a life-sciences discipline qualifying the candidate to act as a Qualified Person.
• 10–15 years of experience in life sciences, with significant experience in quality assurance.
• Proven experience with Blood or Plasma products, ideally as a Qualified Person.
• Experience as an EU Qualified Person is highly preferred; GDP Responsible Person experience is beneficial.
• Knowledge of Blood and Plasma manufacturing techniques, GMP environments, facility qualification, and validation.
• Fluent English is required; another EU language is preferred. Remote work and travel as required are essential.

Nice to have

• Experience with FMEA, FTA, HACCP, and gap assessments.
• Auditing skills.

Culture & Benefits

• Permanent, full-time employment.
• Remote working supported from EU hubs.
• Hybrid office collaboration may be agreed for employees living within a reasonably short commute of an office.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, innovation, and continuous improvement.

Hiring process

• Applications are personally reviewed by the recruitment team.
• Applicants receive an outcome on their application.