Senior Director Quality Assurance (m/f/d)

Senior Director Quality Assurance (m/f/d)

Role:

• Leads Quality Assurance, providing strategic direction and team oversight.

• Ensures compliance with regulations, managing batch releases and product inspections.

• Oversees budget, performance metrics, and improvement initiatives.

• Acts as a key QA contact, supporting production and supply chain teams.

• Conducts shop floor QA activities to address quality concerns.

• Supports audits and inspections, handling all related processes.

• Engages in site projects, aligning with organizational goals.

• Reports to the head of site quality

Qualifications:

• Extensive experience in GxP-regulated pharmaceutical manufacturing, including leadership in quality assurance.

• Expertise in GxP process implementation and batch disposition across global markets (EU, US, Japan).

• Proven auditee in customer audits and regulatory inspections.

• Deep knowledge of GMP, GLP, FDA, and EMA regulations.

• Strong leadership, communication, and decision-making skills under pressure.

• QP/Expert Person qualification is a plus.

• Experienced in risk assessment and mitigation across manufacturing, regulatory affairs, and R&D.

• Analytical, proactive, and patient-focused approach.

• Fluent in German and English.