Senior Auditor, Quality (GMP/GDP) Compliance

BeOne Medicines; Shanghai (WV); Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Auditor for Quality Compliance to ensure adherence to GMP/GDP standards within the pharmaceutical sector. This hands-on role involves executing vendor audits, supporting regulatory inspections, and developing essential SOPs. The ideal candidate will have over a decade of experience in the biotech industry, with a strong grasp of global regulatory requirements and exceptional communication skills. Join a dynamic and inclusive work environment where your contributions will significantly impact compliance and quality assurance efforts.

Benefits

Performance Bonuses

Company Shares

Learning and Development Opportunities

Comprehensive Benefits

Collaborative Work Environment

Qualifications

• 10+ years in the pharmaceutical/biotech industry with GMP/GDP QA experience.
• Strong knowledge of US and EU GMP, GDP, ICH guidelines.

Responsibilities

• Execute external vendor audit program and develop audit reports.
• Support internal GMP/GDP audits and maintain compliance metrics.

Skills

GMP/GDP Compliance

Quality Assurance

Regulatory Compliance

Communication Skills

Analytical Chemistry

Education

Bachelor’s degree in science

CQA Certification

Tools

SOP Development

Audit Reporting

Job description

Senior Auditor, Quality (GMP/GDP) Compliance

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Job Description

General Description: The Senior Manager of GMP/GDP Quality Compliance supports the BeiGene External Vendor Audit program to ensure the regulatory compliance of BeiGene and its vendors. The role involves ensuring that quality and compliance systems adhere to global regulatory and health authority requirements. This position also supports Inspection Readiness by evaluating external guidelines and regulations, and may perform internal audits and support GMP/GDP regulatory inspections. It is a hands-on role within the Global Compliance organization, with global responsibilities and cross-functional influence, primarily involving tactical decision-making. This position is based remotely in China.

Essential Functions of the Role

• Execute the external vendor audit program.
• Lead or participate in GMP/GDP compliance audits, identify gaps or risks, and develop audit reports.
• Support internal GMP/GDP audits and regulatory inspections.
• Maintain and report on GMP/GDP compliance trends and metrics.
• Develop and maintain SOPs and work instructions related to the audit program.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in science or professional certifications.
• 10+ years in the pharmaceutical/biotech industry.
• 5+ years GMP/GDP QA experience, including management; certification as a CQA is desirable.
• Knowledge of US and EU GMP, GDP, ICH guidelines, and international regulations.
• Understanding of biopharmaceutical manufacturing, analytical chemistry, and chemical manufacturing processes.
• Excellent communication, interpersonal, and technical writing skills.
• Ability to multitask and work at a fast pace.
• Working knowledge of applicable regulations such as 21CFR, ICHQ7, Eudralex, Chinese GMP, and ISO standards.

Travel

May require up to 50% travel.

What We Offer

• Competitive compensation including performance bonuses.
• Company shares and equity plans.
• Learning and development opportunities.
• Comprehensive benefits.
• A dynamic, collaborative, and inclusive work environment.

Global Competencies

• Teamwork, feedback, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, data analysis, financial acumen, and clear communication.