Senior Associate: Product Quality & Compliance (GMP)

AOP Health Group; Wien; On-site; EUR 41,000 - 50,000; Full time

Benefits offered by this job

Open corporate culture

Career development opportunities

Flat hierarchies

Bonus potential

Competitive compensation

Job summary

AOP Health Group is seeking a Senior Associate in Product Quality Compliance to manage PQR/APQR processes and stability studies, ensuring regulatory compliance across EU, FDA, and ICH guidelines. You will support Change Control activities and collaborate with cross-functional teams including Regulatory Affairs and CMOs.

The role requires a Bachelor’s degree in a scientific discipline, 3 years in pharma quality, and fluent German and English, with strong writing skills and attention to detail.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 3 years experience in a pharma quality role.
• Experience with Product Quality Reports, Ongoing Stability Studies and change control management.
• Solid GMP knowledge and regulatory expectations (EU, FDA, ICH).
• Strong organizational and analytical skills.
• Experience working with CMOs and cross-functional stakeholders.
• Fluent in German and English (written and spoken).
• Professional technical writing skills.

Responsibilities

• Prepare, review, and maintain annual PQRs and follow up on CAPAs and quality actions.
• Coordinate annual stability studies with CMOs and review stability data.
• Manage Change Controls throughout the product lifecycle.
• Collaborate with Regulatory Affairs, Technical Development, Supply Chain and CMOs.
• Provide quality guidance and KPI monitoring and reporting.

Skills

German fluency

English fluency

GMP knowledge

Analytical skills

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in science

Job description

AOP Health Group is seeking a Senior Associate in Product Quality Compliance to manage PQR/APQR processes and stability studies, ensuring regulatory compliance across EU, FDA, and ICH guidelines. You will support Change Control activities and collaborate with cross-functional teams including Regulatory Affairs and CMOs.

The role requires a Bachelor’s degree in a scientific discipline, 3 years in pharma quality, and fluent German and English, with strong writing skills and attention to detail.