Senior Associate Product Quality Compliance

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

Benefits offered by this job

Open corporate culture

Career development opportunities

Flat hierarchies

Bonus and benefits

Job summary

AOP Health is seeking a Senior Associate Product Quality Compliance to join our Quality Product Compliance team in Vienna. 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. Key responsibilities include coordinating annual stability studies with CMOs, reviewing stability data, driving CAPA actions, and providing quality guidance across

Qualifications

• Bachelor's degree or higher in a relevant scientific field
• 3 years of experience in pharmaceutical quality/manufacturing QC
• Experience with Product Quality Report (PQR), Ongoing Stability Studies (OGS), and change control
• Solid understanding of GMP and regulatory expectations (EU, FDA, ICH)
• Strong organizational and analytical skills with attention to detail
• Experience working with CMOs and cross-functional stakeholders
• Effective communication skills; professional technical writing in German/English

Responsibilities

• Prepare, review, and maintain PQRs; follow up on CAPAs and quality improvement actions
• Coordinate annual stability studies with CMOs; review and trend stability data; support investigations
• Manage Change Controls across product lifecycle; perform impact assessments and documentation
• Collaborate across Regulatory Affairs, Technical Development, Supply Chain, CMOs, and other teams on quality topics
• Provide quality guidance to internal stakeholders and support KPI monitoring, trending, and reporting

Skills

Fluent German

Fluent English

Communication skills

Organizational skills

Analytical skills

Technical writing

GMP knowledge

Cross-functional collaboration

CMO experience

Change control

Education

Bachelor's degree

Job description

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
• Effective communication skills
• 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.