Senior Quality Assurance Manager

November 5

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TFS HealthScience

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CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting

501 - 1000

Description

• Support quality issue management and CAPA management • Ensure compliance and drive continuous improvement across processes • Maintain and approve quality issues and CAPAs in the electronic Quality Management System (eQMS) • Provide support to internal customers with records in quality issues and root cause/CAPA processes • Contribute to improvements in the eQMS and ensure high-quality data metrics and KPIs • Drive quality through proactive support, training, coaching, and consulting • Advise internal teams on addressing issues while ensuring compliance with global regulations • Identify risk areas proactively, offering solutions that align with business needs • Participate in health authority inspections

Requirements

• Extensive experience in Quality Assurance within the pharmaceutical/biotech industry or clinical development • Proficient in managing deviations, quality issues, and CAPA processes • Expertise in continuous improvement methodologies, including Lean Six Sigma • In-depth knowledge of GCP regulations, ICH guidelines, and validation principles (e.g., GAMP5) • Basic understanding of other GxP disciplines, such as GVP, GLP, GRP, and GMP • Strong understanding of QA principles, risk management, and regulatory frameworks • Experience with computerized system development • Fluent in English with excellent communication, problem-solving, and organizational skills • High learning agility, self-motivated, and team-oriented with intercultural awareness

Benefits

• Competitive compensation package • Comprehensive benefits • Opportunities for personal and professional growth