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, GxP, 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, eQMS 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, eQMS 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.