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AO
AOP Health
8d ago

Manager Product Quality Compliance(m/w/x)

Wien
from 45,080 / year
Full-timeWith Home OfficeExperienced

Description

In this role, you will ensure high standards by managing product incidents and complaints while guiding the team through complex investigations and collaborating with CMOs to drive quality.

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Requirements

  • •Degree in Pharmacy, Life Sciences, or related
  • •Advanced degree or Quality Management certification advantageous
  • •3 years pharmaceutical manufacturing or QC experience
  • •Experience with incident management and CAPA
  • •Understanding of GMP and regulatory expectations
  • •Structured mindset and high attention to detail
  • •Experience working with CMOs
  • •Confident communication of quality requirements
  • •Fluency in German and English
  • •Professional technical writing skills

Education

Bachelor's degree
OR
Master's degree

Tasks

  • •Manage product-related incidents and deviations
  • •Handle out-of-specification results and bioburden issues
  • •Investigate cases as a subject matter expert
  • •Implement effective CAPAs and root cause analyses
  • •Guide junior colleagues in incident handling strategies
  • •Oversee product quality complaints and regulatory compliance
  • •Maintain robust documentation and quality trending
  • •Prepare and review standard operating procedures
  • •Support change management for assigned quality topics
  • •Provide quality oversight to cross-functional teams
  • •Identify risks and drive mitigation strategies
  • •Collaborate with CMOs on product quality topics
  • •Monitor and report on quality KPIs
  • •Contribute to continuous improvement initiatives

Tools & Technologies

GMPEU guidelinesFDA guidelinesICH guidelinesCAPAOOS

Languages

German – Business Fluent

English – Business Fluent

Benefits

Informal Culture

  • •Open corporate culture
  • •Collegial and committed team

Purpose-Driven Work

  • •Opportunity to contribute ideas
  • •Independent work

Modern Office

  • •Modern working environment

Parking & Commuter Benefits

  • •Good public transport connections
  • •Parking spot

Flexible Working

  • •Flexible working hours
  • •Homeoffice

More Vacation Days

  • •Time-out days

Bonuses & Incentives

  • •Bonus scheme

Team Events

  • •Employee events

Mentorship & Coaching

  • •Structured onboarding
  • •Buddy system

Modern Equipment

  • •Employee mobile phone
  • •Laptop

Learning & Development

  • •Initial and continuing education

Free or Subsidized Food

  • •Canteen

Healthcare & Fitness

  • •Company doctor
  • •Healthmeasures

Corporate Discounts

  • •Employee discount

Company Vehicle

  • •Company car

Additional Allowances

  • •Meal allowance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AOP Health and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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