Senior Manager, Quality Assurance
Vor 6 Tagen
BeiGene is seeking a highly motivated and experienced Senior Manager, Quality Assurance to join our team. In this role, you will be responsible for ensuring the regulatory compliance status of BeiGene and its vendors through the External Vendor Audit program.
Key Responsibilities:
- Execute the External Vendor Audit program to ensure compliance with global regulatory requirements.
- Lead/participate in GMP/GDP compliance audits to identify gaps or risks and develop corrective actions.
- Develop and issue audit reports and quality events.
- Support GMP/GDP Health Authority Inspections and maintain compliance audit trends and metrics.
- Develop and maintain SOPs and work instructions for the External Vendor Audit program.
Requirements:
- Bachelor's degree in science or professional certifications.
- 10+ years of experience in the pharmaceutical/biotechnology industry.
- 5+ years of GMP/GDP QA experience, with 5 years of management experience and certification as a quality auditor (CQA) desirable.
- Knowledge and understanding of current US and EU Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), and International Conference on Harmonization (ICH) guidelines.
- Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.
Preferred Qualifications:
- Working knowledge and experience with 21CFR210 & 211, ICHQ7, 21CFR600,21CFR11, Eudralex Vol. 4, Chinese GMP 2010, and other international regulations pertinent to BeiGene's global market.
- Working knowledge of applicable ISO Standards.
Travel:
- May require up to 50% travel.
BeiGene Global Competencies:
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- 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
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