Senior Quality Compliance Auditor
vor 2 Wochen
BeiGene is committed to delivering high-quality treatments to patients worldwide. As a Senior Quality Compliance Auditor, you will play a crucial role in ensuring the company's compliance with global regulatory and health authority requirements.
The ideal candidate will have a strong background in quality assurance, with a minimum of 10 years of experience in the pharmaceutical/biotechnology industry. A bachelor's degree in science or relevant certifications is required.
The Senior Manager will be responsible for supporting the External Vendor Audit program, ensuring the regulatory compliance status of BeiGene and vendors. Key responsibilities include:
- Executing the external vendor audit program
- Leading/participating in GMP/GDP compliance audits to ensure compliance with existing policies, procedures, standards, regulations, and guidelines
- Developing, issuing, and managing audit reports and quality events
- Conducting and/or supporting GMP/GDP internal audit program
- Maintaining and reporting GMP/GDP compliance audit trends and metrics
The role requires a strategic thinker with excellent communication and interpersonal skills, as well as a strong understanding of current US and EU Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Knowledge of International Conference on Harmonization (ICH) guidelines and ISO standards is also desirable.
The position is based in Switzerland or Europe and may require up to 50% travel. If you are a motivated and results-driven professional with a passion for quality assurance, we encourage you to apply.
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