Senior Compliance & Quality Assurance Consultant - Qualified Person - Permanent Role

pharmiweb.jobs

Germany, , EU
Hybrid
Qualified person batch certification
Gxp auditing and compliance
Quality management systems development
ProPharma has improved patient health by empowering biotech, med device, and pharmaceutical organizations with regulatory and quality expertise for over 20 years

Job Summary

  • ProPharma has improved patient health by empowering biotech, med device, and pharmaceutical organizations with regulatory and quality expertise for over 20 years.
  • The role involves acting as a Qualified Person and SME in Blood & Plasma quality and compliance, supporting investigational and commercial projects across the EU with remote work and travel.
  • ProPharma promotes diversity, equity, inclusion, and a safe workplace where employees can be authentic and innovative, with a commitment to personal review of all applications without AI screening.

Matching Summary

ProPharma has improved patient health by empowering biotech, med device, and pharmaceutical organizations with regulatory and quality expertise for over 20 years.

Skills & Requirements

Must-have

  • Qualified Person batch certification
  • GxP auditing and compliance
  • Quality Management Systems development
  • Blood and Plasma product expertise
  • Risk-based GxP project execution
  • Remote work with EU travel
  • Subject matter expert in QA

Nice-to-have

  • Fluent in English and EU languages
  • Auditing skills
  • Customer satisfaction improvement
  • Training delivery to clients and associates
  • Collaborative and inclusive workplace
  • Entrepreneurial spirit encouraged

Key Requirements

  • BSc or higher in life sciences
  • Active Qualified Person status in EU
  • 10-15 years QA experience in life sciences
  • Experience with Blood or Plasma products
  • Knowledge of GMP manufacturing for Blood & Plasma
  • Familiarity with risk assessment tools
  • Fluent English language skills

Work Rights

Must be authorized as Qualified Person in the EU

Tailored Resume

Cover Letter