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.
FAQs
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