Regulatory Compliance Specialist, Biopharmaceuticals
Vor 7 Tagen
About the Role
The Senior Manager of GMP/GDP Quality Compliance will play a critical role in ensuring the regulatory compliance status of BeiGene and its vendors. This position requires a strong understanding of global regulatory and health authority requirements, as well as excellent communication and interpersonal skills.
Key Responsibilities
- Execute the external vendor audit program to ensure compliance with existing policies, procedures, standards, regulations, and guidelines.
- Lead/participate in GMP/GDP compliance audits to identify gaps or risks and develop corrective actions.
- Develop, issue, and manage audit reports and quality events.
- Conduct and/or support GMP/GDP internal audit programs.
- Support GMP/GDP health authority inspections.
- Maintain and report GMP/GDP compliance audit trends and metrics.
- Develop and/or maintain SOPs and work instructions pertinent to 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) Good Distribution Practices (GDP), and International Conference on Harmonization (ICH) guidelines.
- Understanding of biopharmaceutical manufacturing, analytical chemistry, and chemical manufacturing business processes.
- Knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety.
- Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.
- Ability to work at a fast pace and multi-task.
- 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.
Computer Skills
- Strong MS Office skills – Outlook, Word, Excel, and PowerPoint.
Travel
- May require up to 50% travel.
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