Senior Associate Product Quality Compliance

AOP Orphan Pharmaceuticals; 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

Senior Associate Product Quality Compliance

We are looking for a Senior Associate Product Quality Compliance to join our Quality Product Compliance team. You will manage PQR/APQR processes and ongoing stability studies to ensure compliance with quality and regulatory requirements. You will also support Change Control activities throughout the product lifecycle.

What Your Day To Day Will Look Like

• Product Quality Reviews (PQR): Prepare, review, and maintain annual PQRs, including reports from CMOs, and follow up on CAPAs and quality improvement actions.
• Ongoing Stability Studies (OGS): Coordinate annual stability studies with CMOs, review and trend stability data, assess potential OOT/OOX results, and support investigations and annual reporting.
• Product Change Control: Manage Change Controls throughout the full lifecycle, including impact assessments, implementation, documentation, and coordination with relevant stakeholders.
• Cross-functional Collaboration: Work closely with Regulatory Affairs, Technical Development, Supply Chain, CMOs, and other teams on product quality topics.
• Quality Support: Provide quality guidance to internal stakeholders and support quality KPI monitoring, trending, and reporting.

Your Qualifications And Experience

• Bachelor's degree / or adequate (e.g. higher technical school in natural science) in a relevant scientific discipline
• 3 years of experience in a similar role within the manufacturing/quality department/QC of pharmaceutical industry
• Experience with Product Quality Report, Ongoing Stability Studies and change control management
• Solid understanding of GMP and regulatory expectations (EU, FDA, ICH guidelines)
• Strong organizational and analytical skills with attention to detail
• Experience working with CMOs and cross-functional stakeholders
• Fluent in German and English (written and spoken)
• professional technical writing skills

Our offer

• Open corporate culture with the opportunity to bring in your own ideas
• Great opportunities for personal and professional development
• Attractive work environment with excellent career opportunities and flat hierarchies
• Competitive salary package plus bonus and various benefits
• Gross annual salary provided for this function is a minimum of EUR 45.080, - based on full-time employment (38,5h/week). Any potential overpayment depends on professional experience and qualifications.