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.
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Language Requirement: Fluent English is Required
Preferred Experience: Pharmaceutical/Biotech Industry
Location: Argentina Remote
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.
This role reports to the Senior Director, Head Inspection Management and Operations, GCOE
Essential Function:
- 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 BeiGene 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, 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 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.
- Supports 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, Global Program Compliance.
- Identifies potential compliance matters and drives the development and implementation of methods for improvement and resolution in a pragmatic and effective manner.
- 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.
- Leads inspection preparation and management for local country and global Health Authority inspections.
- Provides leadership (direction, oversight, guidance and subject matter expertise) to project teams as assigned.
- 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
Minimum Requirements – Education and Experience:
Bachelor’s degree in Life Sciences, Medicine, Quality Management or related field and at least 10 years of relevant experience; or
Master’s degree in Life Sciences, Medicine, Quality Management or related field and at least 7 years of relevant experience. Relevant experience can be in drug development, clinical operations, clinical quality assurance, medical affairs, clinical regulatory compliance or a related field.
Other Experience:
- Has impeccable ethics. Exercises sound judgement and discretion in matters of significance.
- Demonstrated experience with planning, prioritizing, and management of high-level initiatives and projects. Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity. Knowledgeable in stakeholder management and influencing change. Proven interpersonal skills, customer focused approach and effective teamwork and collaboration skills.
- Must demonstrate knowledge of and strong aptitude to learn about the evolving the legal and regulatory environment, ICH GCP, applicable laws, regulations and industry standards as it relates to a global pharmaceutical organization.
- Must understand corporate (local and global) and organization (local and global) policies,
procedures and guidelines.
- Excellent organizational and planning skills; able to prioritize, identify conflicts and meet deadlines without direction.
- Strong verbal and written communication skills. Highly adept at synthesizing and summarizing unusually complex and/or voluminous content in clear, concise, and actionable communications.
- Leverages these skills to work effectively and credibly with leaders across GCO and development.
- Proven ability to lead the analysis and simplification of complex systems or processes into pragmatic solutions. Strong ability to analyze and simplify complex systems. Highly effective in analytical and strategic assessment of GCP compliance risks; able to articulate potential business impact.
- Demonstrated ability to influence and lead both with and without authority in a matrix organization, leading innovation and change
Supervisory Responsibilities:
- May or may not manage direct/indirect reports as needed.
Travel: May be required (10-20%).
Computer Skills: proficiency with computer systems utilized for everyday work: i.e. Word, Excel, PowerPoint, Visio, Outlook etc.
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Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.