Director, Clinical Operations Compliance, GCP

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:

The Director, Clinical Operations Compliance builds, collaborates and manages key relations to better support and understand the compliance-related needs of the business and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and expertise to GCO stakeholders for the compliant conduct of study programs; designs, implements and monitors measures to reduce compliance risks and enhance successful clinical trial conduct. In addition, develops partnerships with key enterprise business partners and stakeholders to advance compliance solutions, embed preventive compliance and enable transparency, escalation, and resolution of quality and compliance matters.

This role reports to the Senior Director, Head Global Program Compliance, GCOE.

Essential Functions of the job:

• Identifies and anticipates potential issues impacting the ability to meet business goals; develops and implements methods of improvement and resolution.
• Independently leads and/or participates in global and cross-functional initiatives, working groups, and project teams as a decision maker, subject matter expert, or reviewer of initiatives and solutions to ensure compliance with ICH GCP, applicable laws and regulations, and consistency within BeOne Quality Management System.
• Works collaboratively with global and regional study teams to ensure that proper root cause assessments, corrective and preventive actions for quality issues, site non-compliance, and process audit findings (as assigned) are in place, and that lessons learnt are disseminated and actioned upon within the broader GCO organization. Identifies and escalates significant compliance issues within GCO and to relevant leadership, including assessment of serious breaches.
• Contributes to the design of study documents, as required, to ensure quality by design and preventative compliance.
• Contributes to the design and implementation of risk identification and management strategies for clinical studies and other regulated drug development activities. Works collaboratively with internal and external business partners and key stakeholders to provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical study conduct and other regulated drug development activities to ensure compliance with ICH GCP, applicable laws and regulations and BeOne policies and procedures.
• Maintains the highest level of expertise in global GCP guidance and regulations, industry best practices, and internal policies and procedures impacting drug development to promote quality and compliance within GCO. Embeds quality principles throughout the organization.
• Designs and conducts, with support from the Inspection Management and Operations team, quality issue trending, analysis, and review activities to proactively identify broader issues and/or patterns within the GCO organization; leads the design and implementation of corrective and/or preventive actions, as applicable; escalates the problems identified with broader organizational impact within GCO and to relevant leadership.
• Reports compliance state of the organization by working together with critical functions in GCOE, such as Learning & Development, TMF, Process Management, Inspection Management, and Operations.
• Identifies potential compliance matters and drives the development and implementation of methods for improvement and resolution pragmatically and effectively. Supports QMS activities, including self-reporting of deviations and quality issues, root cause analysis, and CAPA plan development and evaluation.
• Proactively researches, evaluates, and makes recommendations associated with the organizational impact of evolving laws and regulations. Benchmarks and stays abreast of other industry and marketplace developments and best practices related to drug development quality and compliance.
• Contributes to inspection preparation and management for local country and global Health Authority inspections.
• Provides leadership (direction, oversight, guidance and subject matter expertise) to clinical study teams and project teams as assigned.
  

Supervisory Responsibilities:

• May or may not manage direct and/or indirect reports, as assigned.

Computer Skills:

• Proficiency with computer systems utilized for everyday work: i.e., Word, Excel, PowerPoint, Visio, Outlook, etc.
  

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