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  • Senior Quality Assurance Professional

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Senior Quality Assurance Professional

2 weeks ago

Singapore beBeeCompliance Full time $90,000 - $120,000
Senior Quality Assurance Professional BeiGene is seeking a highly experienced Senior Manager of GMP/GDP Quality Compliance to support the External Vendor Audit program and ensure regulatory compliance status. The ideal candidate will have strong knowledge of global regulations and quality assurance systems.Key Responsibilities: Lead/participate in GMP/GDP compliance audits to identify gaps or risks; Develop, issue and manage audit reports and quality events; Conduct and/or support internal audit program; Support health authority inspections; Maintain and report compliance audit trends and metrics; Develop/maintain SOPs and work instructions.Requirements: Bachelor's degree in science or professional certifications; 10+ years of experience in pharmaceutical/biotechnology industry; 5+ years of GMP/GDP QA experience with management experience; Certification as a quality auditor (CQA) is desirable; Strong MS Office Skills – Outlook, Word, Excel, and PowerPoint; Knowledge of current US and EU Good Manufacturing Practices (GMP) Good Distribution Practices (GDP), and International Conference on Harmonization (ICH) guidelines.What We Offer: Market competitive compensation package including performance-based annual bonus scheme; Company shares; In-house and external learning and development opportunities; Fantastic benefits program and keep improving.Competencies: Fosters Teamwork; Provides and Solicits Honest and Actionable Feedback; Self-Awareness; Acts Inclusively; Demonstrates Initiative; Entrepreneurial Mindset; Continuous Learning; Embraces Change; Results-Oriented; Analytical Thinking/Data Analysis; Financial Excellence; Communicates with Clarity.