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CACatalent

Director Quality(m/w/x)

Eberbach
Full-timeOn-siteManagement

Ensuring GMP compliance for drug delivery forms at global manufacturer with 7,000+ products, leading a 100-person team. Degree in Pharmacy, Chemistry, or Biology, plus pharmaceutical regulatory compliance and management experience required. Application support for disability.

Requirements

  • Degree in Pharmacy, Chemistry, or Biology
  • Experience in pharmaceutical quality management
  • Knowledge of GMP regulations and standards
  • Experience in managing audits and inspections
  • Understanding of pharmaceutical manufacturing processes
  • Excellent leadership and people management skills
  • Strategic thinking and problem-solving ability
  • Strong communication in German and English
  • High integrity and compliance orientation
  • Ability to manage complex projects
  • Strong customer focus and advisory skills
  • Familiarity with digital quality systems

Tasks

  • Lead a quality organization of nearly 100 employees
  • Prioritize patient safety and product quality in all decisions
  • Select, manage, and evaluate departmental staff
  • Ensure compliance with international GMP and legal requirements
  • Implement global quality policies into local processes
  • Advise customers on quality-related matters and service
  • Align departmental tasks with corporate economic objectives
  • Meet annual operational revenue and performance targets
  • Oversee testing of raw materials and finished pharmaceuticals
  • Support process and cleaning validations with analytical data
  • Prepare master orders and manufacturing documents
  • Manage the release of bulk and finished products
  • Coordinate regulatory, customer, and supplier audits
  • Conduct internal self-inspections and quality audits
  • Manage complaints, deviations, and regulatory matters
  • Maintain a quality reporting system for process improvement
  • Oversee computer validation and equipment qualification
  • Manage SOP systems and GMP training programs
  • Optimize processes while maintaining legal compliance
  • Share quality-related information across corporate sites
  • Execute special projects assigned by leadership

Work Experience

  • 5 - 10 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • EU GMP
  • AMWHV
  • 21 CFR 210/211
  • Digital quality systems
  • Process optimization tools

Benefits

Career Advancement

  • Karrieremöglichkeiten

Other Benefits

  • Bewerbungsunterstützung bei Behinderung
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