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 drugProven 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]