Auf einen Blick
- Aufgaben: Leite das Qualitätskontrollteam und verbessere kontinuierlich unsere Laborprozesse.
- Unternehmen: Führendes Unternehmen in der pharmazeutischen Industrie mit einem Fokus auf Qualität.
- Vorteile: Attraktives Gehalt, Weiterbildungsmöglichkeiten und ein dynamisches Arbeitsumfeld.
- Weitere Informationen: Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung in einem internationalen Team.
- Warum dieser Job: Gestalte die Zukunft der Qualitätssicherung in einer innovativen Branche.
- Qualifikationen: Erfahrung in der Qualitätskontrolle und Führungskompetenz in regulierten Umgebungen.
Das prognostizierte Gehalt liegt zwischen 56250 - 68750 € pro Jahr.
We are looking for an experienced Head of Quality Control to lead and develop the Quality Control function within a highly regulated pharmaceutical environment.
This is a senior leadership position with responsibility for ensuring the quality, compliance and performance of QC operations, while driving continuous improvement across laboratory processes, systems and analytical activities.
The role will work closely with Quality Assurance, Manufacturing, Supply Chain, Regulatory Affairs and IT and will play a key role in the ongoing development of the site's quality and digital infrastructure.
Key Responsibilities Lead the overall Quality Control function, providing strategic and operational direction across analytical and laboratory activities.
Ensure QC operations remain compliant with GMP/GDP, Gx P, data integrity and applicable regulatory requirements.
Oversee analytical testing, review and approval of results, stability activities, investigations, OOS/OOT processes and analytical documentation.
Drive the effective use and continuous improvement of LIMS, SAP QM, e QMS and other laboratory/quality systems.
Ensure robust management of pharmaceutical master data, specifications, analytical methods and quality-related system data.
Lead and develop the QC team, setting clear objectives, supporting capability development and building a strong quality culture.
Own or provide senior oversight of deviations, CAPAs, change controls and quality investigations within QC.
Support regulatory inspections, customer audits and internal audits, ensuring the QC organisation remains inspection-ready.
Lead or support method validation, method transfer, equipment qualification and computerised system validation activities.
Assess changes to laboratory processes and systems from a compliance, data integrity, quality and business-impact perspective.
Establish and monitor QC performance through KPIs, quality metrics and trend analysis, identifying opportunities for improvement.
Represent QC in major digital transformation and system implementation projects, including SAP S/4HANA and other quality technology initiatives.
Work closely with QA, Manufacturing, Regulatory Affairs, Supply Chain and IT to harmonise processes and improve overall quality performance.
Manage QC resources and contribute to budgeting, business cases and strategic investment decisions.
Ideal Candidate Senior QC/Quality leader with significant experience within pharmaceutical, biotech or another highly regulated environment.
Strong technical background in analytical QC, GMP, laboratory operations and quality systems.
Proven leadership experience managing and developing multidisciplinary QC teams.
Strong understanding of OOS/OOT, deviations, CAPA, change control, investigations, validation and data integrity.
Experience with LIMS, SAP QM, e QMS and/or laboratory digital transformation.
Comfortable working at both strategic and operational level and influencing senior stakeholders.
Strong understanding of regulatory expectations and experience supporting audits and inspections.
Fluent German and English.
Head of Quality Control in Darmstadt 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.
