Senior Manager, GCP Auditor

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.

General 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 knowledge and/or awareness of GLP/GCLP and experience in conduct and reporting of GLP/GCLP audits (mainly for China located auditors responsible for GLP/GCLP audits)
• 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)
• 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:

• 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 & Documentation : Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions; Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures and ensure effective CAPA are provided by auditee; maintain well-organized and accurate audit documentation for regulatory and internal purposes.
• Escalate systemic, critical and/or major audit findings and recommend appropriate solutions to senior management for immediate and long-term resolution.
• Work with leadership to establish processes and standards for excellence in R&D audits, responses, CAPAs and effectiveness checks to optimize effective and consistent performance within R&D Quality and for R&D stakeholders.
• Support the process of developing audit programs for clinical studies and oversee the programs on a quarterly basis or as required.
• Participate in & support GCP, GVP & GLP authority inspections (FDA, EMA, PMDA, TGA, CFDI etc.,) in assigned roles such as back-room support, inspection hosting support, inspection & pre-inspection preparation support (site and sponsor).
• Provide professional expertise and strong leadership in GCP guidance and regulations to internal stakeholder with R&D Quality and other functions within the company.

Minimum Requirements – Education and Experience: