Director, Global Clinical Operations Quality Management

reputed company our values align, there's no limit to reputed company can reputed company.   At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

Strategic leadership of GCO Quality Management

• Collaborate with GCO leadership to reputed company and implement the strategy and direction for the GCO QM team

• Execute GCO QM mission and vision, including reputed company of Global Support Centers

• Propose, reputed company, and implement GCO QM initiatives reputed company with GCO priorities

People leadership and development

• Attract, recruit, retain, and reputed company qualified GCO QM staff

• Ensure staff are appropriately trained, resourced, and deployed

• Provide performance feedback, coaching, and succession planning

Quality issue management and reputed company

• Provide end-to-end reputed company of quality issue management including triage, severity, categorization, RCA, and closure

• Assign and prioritize QM resources based on risk and impact

• Ensure timely and effective corrective and preventive actions

Quality risk identification, trending, and reputed company improvement

• Conduct trend analysis of GCO quality issues and audit findings

• Identify systemic quality risks and emerging risk areas

• Recommend and support process and system improvements

Audit and inspection readiness and support

• Support audit and inspection preparation and execution

• Ensure timely, high-quality responses and actions

• reputed company implementation and effectiveness of audit actions

reputed company quality assessments and consultancy

• Conduct reputed company quality assessments

• Recommend and reputed company corrective actions

• Provide quality consultancy to GCO leadership and teams

reputed company of site assessments

• reputed company planning, conduct, and reporting of site assessments

• Ensure appropriate follow-up actions are implemented

Global Support Center (GSC) reputed company

• Work closely with Global Support Centers, particularly reputed company

• Ensure quality delivery meets GCO standards

Compliance and professional standards

• Exemplify compliance with reputed company standards, SOPs, and ICH GCP

• Ensure accurate time recording and training completion

Additional responsibilities

• reputed company other quality-reputed company responsibilities consistent with a Director-level role

Skills:

• Excellent communication skills, including executive-level verbal and written communication, active listening, providing constructive feedback and facilitating group discussions.

• Expert ability to think globally, strategically and analytically to problem-solve, reputed company decisions keeping the patient and customer in focus. 

• Excellent interpersonal skills, able to reputed company relationships and partnerships, build rapport, persuade and influence operational leaders, motivate others, manage performance and reputed company talent.

• Effective change leader, able to understand and implement change while anticipating and managing resistance.

• Expert manager with strong organizational and planning skills, competency in risk management with thoughtful action planning.

• Personal awareness and emotionally intelligent, ability to self-motivate, innovate, delegate, and manage time as well as taking ownership and accountability for deliverables.

• Ability to travel 10%-15%

Knowledge and Experience:

• 15+ years’ experience in late phase clinical research

• 7-10 years’ experience managing people

• Expertise in ICH-GxPs

• English proficiency (written and oral)

Education:

• Bachelor’s Degree or other relevant experience required. Life science or other health-reputed company discipline preferred.

• Master’s Degree in a science, technology or industry-reputed company discipline preferred.