Senior Associate Product Quality Compliance

Full-time Vienna

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.

APPLY NOW

Please submit your application exclusively via the application link.

Main Benefits

Bonus

Homeoffice

Employee mobile phone

Flexible working hours

Laptop

Initial and continuing education

Canteen

Good transport connection

Employee events

Meal allowance

Company doctor

Parking spot

Healthmeasures

Employee discount

Your Contact

Kenny Trappl

Talent Acquisition Manager

Needs. Science. Trust.

As a privately owned company, AOP Health is devoted to long-term commitment, high quality, and continuity. For a small number of very special diseases the company is sole supplier of some key therapeutic agents throughout the world.