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Director of Quality Assurance Operations

Director of Quality Assurance Operations

Discover InternationalFrankfurt, Hesse, Germany
Vor 21 Tagen
Stellenbeschreibung

Title : Director of QA Operations

Location : Hybrid based in Frankfurt, Hesse, Germany

The Company :

The company boasts a robust pipeline of proprietary biologics and small molecules, with a strong emphasis on research and development. Known for its leading products in areas such as autoimmune disorders and oncology, they combines scientific expertise with a patient-centred approach to healthcare, aiming to address some of the most challenging health issues worldwide.

Responsibilities :

  • Provide oversight for Quality systems and performance metrics to ensure high standards.
  • Lead the Quality Assurance team to foster employee development and effective succession planning.
  • Actively contribute to Performance Excellence initiatives.
  • Manage costs effectively, meet budget targets, and strive for improved bottom-line growth.
  • Prioritize decisions with significant financial implications, foresee obstacles, and implement solutions; oversee strategic projects.
  • Ensure compliance with safety and environmental regulations as they pertain to Quality Assurance.
  • Monitor Quality performance and regulatory adherence via internal audits, metrics, and trend analysis.
  • Spearhead inspection readiness activities and represent the site during inspections, audits, and global compliance initiatives.
  • Serve as the acting Site Quality Director when needed.

Requirements :

  • At least 8 years of experience in the pharmaceutical industry, ideally encompassing both drug
  • Proven leadership abilities with experience in managing large teams.
  • Demonstrated expertise in Operations Quality Assurance for a minimum of 5 years.
  • Strong understanding of current Good Manufacturing Practice (cGMP) regulations (e.g., EU / US) and expectations of regulatory agencies.
  • Experience in managing inspections directly.
  • In-depth knowledge of the Operations business.
  • Proficient in both German and English, with business-level fluency.
  • Passionate about performance and innovation.
  • If interested please apply or reach out to me with any questions on; [email protected]