Director, Global Clinical Operations, Compliance

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Establish, collaborate, and nurture essential relationships to facilitate compliance-related business objectives within Global Clinical Operations.

• Offer quality guidance, direction, and expertise to ensure the compliant execution of study programs.

• Design, implement, and oversee measures aimed at minimizing compliance risks and improving clinical trial execution.

• Forge partnerships with enterprise business partners and stakeholders to promote compliance solutions and integrate preventive compliance measures.

• Lead or engage in global and cross-functional initiatives, working groups, and project teams.

• Ensure adherence to ICH GCP, relevant laws and regulations, and the BeiGene Quality Management System.

• Spearhead root cause analyses, corrective and preventive actions, and lessons-learned initiatives for quality concerns, site non-compliance, audits, and inspections.

• Recognize and escalate significant compliance challenges, including serious violations.

• Contribute to strategies for risk identification and management in clinical studies and regulated drug development activities.

• Provide consultative guidance on the systems, processes, procedures, regulations, and tools utilized in clinical studies.

• Maintain expertise in global GCP guidelines, regulations, industry best practices, and internal policies.

• Support analysis, trending, and review of quality issues; lead corrective and preventive actions.

• Deliver actionable quality and compliance insights and data to GCO leadership.

• Report on the organization's compliance status concerning critical GCOE functions.

• Investigate evolving laws and regulations, recommending actions based on industry benchmarks and best practices.

• Lead preparations and management for local-country and global Health Authority inspections.

• Provide leadership, oversight, guidance, and subject matter expertise to assigned project teams.

• Supervise direct and indirect reports while supporting their mentoring, coaching, and professional growth.

• Conduct staff meetings and offer performance reviews and career development feedback.

• Manage budgets for assigned projects/activities and remain aware of the GCO Compliance project portfolio.

⛳️ Requirements

• Proficiency in English is essential.

• Preferably possess experience within the pharmaceutical or biotech sectors.

• Hold a Bachelor’s degree in Life Sciences, Medicine, Quality Management, or a related field with a minimum of 10 years of relevant experience; or a Master’s degree in these areas with at least 7 years of pertinent experience.

• Relevant background in drug development, clinical operations, clinical quality assurance, medical affairs, clinical regulatory compliance, or a related domain.

• Unwavering ethics, sound judgment, and discretion.

• Demonstrated experience in planning, prioritizing, and managing high-level initiatives and projects.

• Knowledge of stakeholder management and the ability to influence change.

• Familiarity with ICH GCP, applicable laws, regulations, and industry standards.

• Understanding of corporate and organizational policies, procedures, and guidelines.

• Strong organizational, planning, prioritization, verbal, and written communication skills.

• Capability to distill complex or extensive content into clear, concise, and actionable communications.

• Ability to analyze and simplify complex systems or processes into practical solutions.

• Competence in assessing GCP compliance risks and articulating potential business implications.

• Ability to influence and lead both with and without authority in a matrix organization.

• Proficiency in Word, Excel, PowerPoint, Visio, and Outlook.

• May oversee direct or indirect reports as required.

🏝️ Benefits

• May require travel of 10–20%.

• Equal opportunity employment.