Senior Manager of Quality Compliance
Vor 7 Tagen
BeiGene is committed to getting more affordable medicines to patients worldwide. As a Senior Manager of Quality Compliance, you will play a critical role in ensuring the company's global compliance status with regulatory requirements.
The role is part of the External Vendor Audit program, which aims to ensure BeiGene's compliance with applicable global regulations and health authority requirements. You will be responsible for evaluating external guidelines and regulations, identifying emerging standards that affect the business, and ensuring visibility and awareness among stakeholders.
As a Senior Manager, you will also lead/participate in GMP/GDP compliance audits, develop and issue audit reports, and manage quality events. Additionally, you will conduct and support GMP/GDPP BeiGene Internal audit program, support GMP/GDP Health Authority Inspections, and maintain and report GMP/GDP compliance audit trends and metrics.
The ideal candidate will have a Bachelor's degree in science or professional certifications, 10+ years of experience in the pharmaceutical/biotechnology industry, and 5+ years of GMP/GDP QA experience with management experience. Knowledge of US and EU Good Manufacturing Practices (GMP) Good Distribution Practices (GDP), International Conference on Harmonization (ICH) guidelines, and Biopharmaceutical Manufacturing, Analytical Chemistry, and Chemical Manufacturing processes is required.
The selected candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with regulatory requirements, and identifying areas for improvement. If you have a passion for quality assurance, are highly motivated, and have excellent communication skills, we encourage you to apply for this exciting opportunity.
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Basel, Basel-Stadt, Schweiz BeiGene Vollzeit{"title": "Senior Manager, Quality Assurance", "content": "Job SummaryBeiGene is seeking a highly motivated and experienced Senior Manager, Quality Assurance to join our team. As a key member of our Global Compliance organization, you will be responsible for ensuring the regulatory compliance status of BeiGene and our vendors.Key ResponsibilitiesDevelop and...
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