We are seeking an experienced quality leader to oversee global QA, compliance, and product integrity across clinical and commercial supply. You will ensure GMP and GDP compliance across packaging, labelling, serialization, storage, and distribution, safeguarding product quality, patient safety, and inspection readiness.
Your Responsibilities
- Lead global supply quality strategy, overseeing and maintaining compliance, and inspection readiness.
- Ensure serialization, data integrity, and product traceability across global markets and partners.
- Oversee the transition to commercial supply, including change management, scale-up, and market expansion.
- Ensure GDP compliance across storage, transport, cold chain, and global trade.
- Lead investigations, CAPAs, recalls, and supply incidents, driving risk management and continuous improvement in line with ICH Q9 and Q10.
- Partner with cross-functional teams and external stakeholders to define quality responsibilities and maintain effective quality agreements.
Your Profile
- Relevant Scientific degree.
- More than 10 Years of Quality experience in the Pharmaceutical industry.
- Experience in packaging, labelling, serialization, storage, distribution, and external partner oversight.
- Strong knowledge of global regulatory requirements (FDA, EMA, WHO)
- Background in GMP/GDP environments.
- Strong risk management, problem-solving, and continuous improvement skills.
- Flexibility: Flexible hours and vacation account.
- Development: Digital learning, leadership development, performance and talent development, apprenticeships, and LinkedIn Learning.
- Culture & Impact: A collaborative, inclusive culture with opportunities to influence decisions and shape the business.
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Senior Director Quality in Frankfurt am Main Arbeitgeber: Discover International
Als Arbeitgeber in der biopharmazeutischen Fertigung bieten wir Ihnen die Möglichkeit, in einem dynamischen Umfeld zu arbeiten, das auf Innovation und Qualität ausgerichtet ist. Unsere Unternehmenskultur fördert Teamarbeit und kontinuierliches Lernen, während wir Ihnen durch gezielte Schulungen und Entwicklungsmöglichkeiten helfen, Ihre Karriere voranzutreiben. Darüber hinaus profitieren Sie von einem modernen Arbeitsplatz, der mit den neuesten Technologien ausgestattet ist, und einer flexiblen Arbeitsumgebung, die Ihre Work-Life-Balance unterstützt.
