Senior Manager, GCP Auditor

Job Title: Senior Manager, GCP Auditor

Job Location: Japan

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

About us

BeOne 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 BeOne, please visitwww.beonemedicines.comand follow us on LinkedIn and X (formerly known as Twitter).

BeOne 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:This position within R&D Quality is a senior Auditor role (as Lead or Co-auditor) who is responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP regulations and industry standards, in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.

The position will play a critical role in safeguarding the integrity, safety, and quality of clinical research processes and data.

This position requires:

• Extensive knowledge and/or awareness of ICH GCP and applicable global & local regulations and guidance for clinical development.

• Strong global mindset and knowledge about regulations (specific expertise regulations/ requirements/ culture awareness)

• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

• Extensive experience in managing GCP investigations.

• Experience in product/compound lead/consultancy (GCP)

• Extensive or Direct experience with supporting and involvement in GCP inspections (main inspectorates (FDA, EMA, CFDI etc.,)) and other country specific inspectorates (MFDS, PMDA, TGA etc., based on location of position)

• Provide GCP guidance for all phases of drug development for assigned clinical compounds/projects.

• Lead or support development of GCP quality metrics and measures to drive assessment and continuous improvement.

• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.

• Effective technical writing skills; able to write quality positions, audit reports, and procedures.

• Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.

• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.

Essential Functions of the job:

• Audit Planning & Preparation : Operationalize approved audit plans and strategies for R&D GCP audits (External & Internal audits), considering relevant regulations and industry standards; Coordinate audit schedules and necessary resources with relevant stakeholders: Review documentation, procedures, and quality management systems prior to conducting audits.

• Conducting Audit : Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant guidelines; Document audit findings, deviations, and areas of non-compliance; Interview personnel, review records, and gather evidence during audits.

• **Reporting & Documentati...