GVP Inspection Lead, APAC, Associate Director

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GVP Inspection Lead, APAC, Associate Director Apply locations Singapore time type Full time posted on Posted 4 Days Ago job requisition id R24443

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

About BeiGene:

BeiGene (NASDAQ: BGNE; HKEX: 06160; SHA: is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of over 10,000 colleagues across five continents.

About the Position:

General Description:

The GVP Quality Lead, is responsible for supporting the Director GVP Quality in implementing and maintaining a balanced, proactive, global approach to GVP Quality Assurance. This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices.

Essential Functions of the job:

• Conduct and support quality assurance (QA) activities related to applicable PV regulatory requirements, guidelines, laws and internally established standards, procedures and practices for all phases of drug development
• Participate and support as member of the GVP QA team to enhance performance and maintain accountability for the implementation of QA systems
• Develop/improve and manage quality systems and processes to include:
• Conducting/managing routine/for cause audit of vendors, partner, internal audits etc.
• Supporting the activities related to the vendor management process training, SOPs, etc.
• Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits
• Developing and managing Integrated Quality Management Risk plans
• Conducting/managing review of key PV documents
• Developing quality metrics and measures to drive assessment and continuous improvement
• Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
• Coordinate and/or administer GCP/GVP training, as needed
• Participate in the review of metrics (i.e. deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements
• Coordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and management
• Expert knowledge of GVP requirements
• Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment
• Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
• Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations
• Participate and represent R&D Quality in meetings and discussions, as needed
• Other duties as assigned

Supervisory Responsibilities:

• Expert knowledge of GVPs and GCP requirements
• Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Promote continuous improvements in quality systems and department infrastructure; assist with creation / revision of appropriate SOPs
• Proven ability in driving quality process improvement initiatives
• Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations

Qualification Required:

What we offer to our valued employees:

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving

Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.

Due to BeiGene's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene's Job Applicant Privacy Policy ( ).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

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BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter).

To Mainland China Candidates

For more information, please visit the link to explore job opportunities in China Mainland.

At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.
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