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Salary: EUR 60,212 - 105,200 / annual
DTX Pharma (a Novartis company) seeks a QA Compliance Expert to manage quality assurance and regulatory compliance within their Kundl, Austria manufacturing facility. This role ensures operational adherence to cGMP (Current Good Manufacturing Practices), Novartis Quality Manual standards, and relevant SOPs.
Key responsibilities include: managing GMP compliance for contractors and suppliers (QA agreements, audit planning, quality risk assessments, audit tracking); organizing and coordinating audits and inspections by regulatory bodies, Novartis, and customers; preparing inspection and audit summaries, developing corrective action plans, and drafting responses to regulatory findings; providing customer support on quality matters related to submissions and inspections; coordinating regulatory requests for submissions and GMP renewals; supplying data for monthly reporting and APQRs (Annual Product Quality Reviews); authoring SOPs within the area of responsibility; and overseeing quality improvement projects.
Required qualifications: completed degree in natural sciences (chemistry, microbiology, biology, pharmacy, biotechnology) or equivalent multi-year professional experience; minimum 2 years of professional experience, preferably in GMP-regulated pharmaceutical environments; initial experience with compliance in QA, QC, or production; strong organizational skills; fluent German and English.
Novartis offers competitive base salary (€60,212–€105,200 annually), performance bonuses, modern pension, childcare facilities, training programs, and global career opportunities. The company supports flexible work arrangements and home office options where feasible. Open to part-time and job-sharing models.
