Senior Auditor, Quality (GMP/GDP) Compliance About us
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).
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: General Description:
The Senior Manager of GMP/GDP Quality Compliance supports the BeiGene External Vendor Audit program to ensure the regulatory compliance status of BeiGene and vendors. The Senior Manager ensures that quality and compliance systems follow applicable global regulatory and health authority requirements. This role supports Inspection Readiness and as such the Senior Manager evaluates external guidelines and regulations, ensuring visibility and awareness of emerging new or changing standards that affect the business of BeiGene. The Senior Manager GMP/GDP Compliance may also perform internal audits (BeiGene Sites, CMO's, and affiliates) and supports GMP/GDP regulatory inspections. This position is a hands-on role within the Global Compliance organization with global responsibility and cross-functional influence requiring primarily tactical decision making. This position is China Remote based.
Essential Functions of the role: Execute the external vendor audit program. Independently lead/participate in GMP/GDP compliance audits to ensure compliance with existing policies, procedures, standards, regulations, and guidelines and identify gaps or risks. Develop, issue and manage audit reports and any associated quality events. Conduct and/or support GMP/GDP BeiGene Internal audit program. 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. Other duties as assigned. Supervisory Responsibilities:
This position may include managing globally located staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required.
Qualification Required: Computer Skills: Strong MS Office Skills - Outlook, Word, Excel, and PowerPoint. Other Qualifications: Bachelor's degree in science or Professional Certifications. 10+ years #J-18808-Ljbffr