Director, Clinical Operations Compliance
vor 1 Monat
General Description:
The Director Global 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. May act as a deputy to co
- chair the GCP council.
This role reports to the Senior Director, Global Clinical Operations Compliance Lead.
**Responsibilities**:
- Identifies and anticipates potential issues impacting the ability to meet business goals; develops and implements methods of improvement and resolution.
- 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, audit and inspection findings 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 strategy 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 BeiGene policies and procedures.
- Maintains the highest level of expertise in global GCP guidance’s 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.
- Provides input and support to CRO Joint Committee Forums through consultative guidance on the development of the key defining principles and documents.
- Designs and conducts quality issue trending, analysis and review activities to proactively identify broader issues and/or patterns within GCO organization; leads the design and implementation of corrective and/or preventive actions, as applicable; escalates the identified issues with broader organizational impact within GCO and to relevant leadership.
- Ensures provision of actionable data and insights regarding the state of quality and compliance to GCO leadership and other stakeholders as requested i.e., GCOE.
- Reports compliance state of the organization by working together with critical functions in GCOE, such as Learning & Development, TMF, process management, Inspection Readiness
- Identifies potential compliance matters and drives the development and implementation of methods for improvement and resolution in a pragmatic and effective manner. 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 organizational impact of evolving laws and regulations. Benchmarks and stays abreast of other industry and marketplace developments and best practices as it relates to drug development quality and compliance.
- Contributes to inspection preparation and management for local country and global Health Authority inspections.
- Oversees the work of indirect/direct reports, as assigned, to ensure on-time, on-target and within-budget results. Provide ongoing mentoring, coaching, guidance and feedback to ensure indirect/direct reports are successful in their work, as well as have the necessary and timely access to information and other resources. Supports the professional development of direct/indirect reports, as applicable.
- Conducts regular one-one-one and any other staff meetings to ensure timely communication with indirect/direct reports. Provides feedback on formal performance reviews and career development planning for all indirect reports.
- Manages budget for assigned projects and/or activities. Maintains operational and budgetary awareness of overall GCO Compliance project portfolio, as applicable.
Supervisory Responsibilities:
- May or may not manage direct/indirect reports as needed
Education Required:
Bachelor’s degree in Life Sciences,
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