Senior QA & Compliance Consultant — Qualified Person

ProPharma Group; Germany (OH); On-site; USD 120,000 - 170,000; Full time

Job summary

ProPharma Group seeks a Senior Compliance & Quality Assurance Qualified Person Consultant on a permanent basis, with option for remote work. You will provide SME leadership across QA projects for Life science clients, including MIA/WDA activities and QP certification processes.

You will apply 10+ years of GxP QA experience, preferably with US FDA, ICH, EMA, and MHRA knowledge, and lead risk-based, phase-appropriate quality initiatives while training clients and colleagues.

Qualifications

• At least a BSc in Pharmacy or a related discipline.
• 10+ years of QA experience in GxP environments.
• 2–3 years of experience as a Qualified Person.
• Strong knowledge of US FDA, ICH, EMA, MHRA regulatory landscape.
• Fluent English; knowledge of another EU language is a plus.
• Excellent project management and stakeholder skills.

Responsibilities

• Provide SME and leadership on QA projects including MIA/WDA.
• Lead QA activities such as QP certification, GxP audits, QMS development.
• Promote continuous improvement and CAPA implementation.
• Train clients and internal teams on QA and compliance.
• Ensure company operations align with quality principles.

Skills

Quality Assurance

GxP

Project management

Regulatory knowledge

Cross-functional collaboration

English fluency

Education

Bachelor's degree in Pharmacy

BSc or equivalent in a related discipline

Job description

ProPharma Group seeks a Senior Compliance & Quality Assurance Qualified Person Consultant on a permanent basis, with option for remote work. You will provide SME leadership across QA projects for Life science clients, including MIA/WDA activities and QP certification processes.

You will apply 10+ years of GxP QA experience, preferably with US FDA, ICH, EMA, and MHRA knowledge, and lead risk-based, phase-appropriate quality initiatives while training clients and colleagues.