Manager Product Quality Compliance (m/f/d)

Overview

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a: Manager Product Quality Compliance (m/f/d) — location 1190 Vienna, Full-time. Start: as of now.

As Manager Product Quality Compliance , you are a key operational quality partner ensuring compliant handling of product-related quality topics across the product lifecycle. You are responsible for product related incidents and complaints, support colleagues in investigations, and collaborate closely with internal stakeholders and external CMOs to maintain high product quality standards.

Responsibilities

• Product Quality & Incident Management
  • Manage product-related incidents, including out-of-specification (OOS) results, bioburden and particle issues, deviations
  • Act as quality function, investigator, and/or subject matter expert for assigned cases
  • Ensure timely, compliant investigations, root cause analyses, and implementation of effective CAPAs
  • Functionally guide and coach more junior colleagues in the team in incident handling, including investigation strategy, root cause analysis, documentation, and CAPA definition
• Complaint Handling
  • Oversee and handle product quality complaints in compliance with regulatory and internal requirements
  • Ensure robust documentation, trending, and escalation where required
• Quality Systems & Documentation
  • Prepare, review, and maintain SOPs and quality-related documentation
  • Support change management activities for assigned quality topics where applicable
• Collaboration & Quality Support
  • Serve as a subject matter expert for out-of-specification (OOS) results, bioburden and particle issues, deviations
  • Provide quality oversight and guidance to cross-functional teams (e.g. Regulatory, Tech. Development)
  • Proactively identify quality risks and drive mitigation strategies
  • Collaborate closely with CMOs on product quality topics
• Performance & KPI Management
  • Support quality KPI definition, monitoring, trending, and reporting
  • Contribute to continuous improvement initiatives based on operational quality data

Qualifications and Experience

• University degree in Pharmacy, Life Sciences, (Bio)Chemistry, Biotechnology, or a related field
• Advanced degree (MSc, PhD) or professional certification in Quality Management / GMP is an advantage
• 3 years of experience in a similar role within the manufacturing/quality department/QC of pharmaceutical industry
• Strong hands-on experience with incident management, deviations, OOS, complaints, and CAPA
• Solid understanding of GMP and regulatory expectations (EU, FDA, ICH guidelines)
• Structured, solution-oriented mindset with high attention to detail
• Experience working with CMOs, including the ability to challenge quality topics constructively in a professional manner
• Confident communicator, able to explain quality requirements clearly to internal/external partners
• Fluent in German and English (written and spoken)
• Professional technical writing skills

Our offer

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45,080 gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: