Job Description
Strategic leadership of GCO Quality Management
• Collaborate with GCO leadership to develop and implement the strategy and direction for the GCO QM team
• Execute GCO QM mission and vision, including oversight of Global Support Centers
• Propose, lead, and implement GCO QM initiatives aligned with GCO priorities
People leadership and development
• Attract, recruit, retain, and develop qualified GCO QM staff
• Ensure staff are appropriately trained, resourced, and deployed
• Provide performance feedback, coaching, and succession planning
Quality issue management and oversight
• Provide end-to-end oversight 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 continuous 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
• Oversee implementation and effectiveness of audit actions
Ad hoc quality assessments and consultancy
• Conduct ad hoc quality assessments
• Recommend and oversee corrective actions
• Provide quality consultancy to GCO leadership and teams
Oversight of site assessments
• Oversee planning, conduct, and reporting of site assessments
• Ensure appropriate follow-up actions are implemented
Global Support Center (GSC) oversight
• Work closely with Global Support Centers, particularly APAC
• Ensure quality delivery meets GCO standards
Compliance and professional standards
• Exemplify compliance with Parexel standards, SOPs, and ICH GCP
• Ensure accurate time recording and training completion
Additional responsibilities
• Perform other quality-related 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, make decisions keeping the patient and customer in focus.
• Excellent interpersonal skills, able to develop relationships and partnerships, build rapport, persuade and influence operational leaders, motivate others, manage performance and develop 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-related discipline preferred.
• Master’s Degree in a science, technology or industry-related discipline preferred.
• Collaborate with GCO leadership to develop and implement the strategy and direction for the GCO QM team
• Execute GCO QM mission and vision, including oversight of Global Support Centers
• Propose, lead, and implement GCO QM initiatives aligned with GCO priorities
People leadership and development
• Attract, recruit, retain, and develop qualified GCO QM staff
• Ensure staff are appropriately trained, resourced, and deployed
• Provide performance feedback, coaching, and succession planning
Quality issue management and oversight
• Provide end-to-end oversight 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 continuous 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
• Oversee implementation and effectiveness of audit actions
Ad hoc quality assessments and consultancy
• Conduct ad hoc quality assessments
• Recommend and oversee corrective actions
• Provide quality consultancy to GCO leadership and teams
Oversight of site assessments
• Oversee planning, conduct, and reporting of site assessments
• Ensure appropriate follow-up actions are implemented
Global Support Center (GSC) oversight
• Work closely with Global Support Centers, particularly APAC
• Ensure quality delivery meets GCO standards
Compliance and professional standards
• Exemplify compliance with Parexel standards, SOPs, and ICH GCP
• Ensure accurate time recording and training completion
Additional responsibilities
• Perform other quality-related 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, make decisions keeping the patient and customer in focus.
• Excellent interpersonal skills, able to develop relationships and partnerships, build rapport, persuade and influence operational leaders, motivate others, manage performance and develop 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-related discipline preferred.
• Master’s Degree in a science, technology or industry-related discipline preferred.
💡 Quick Summary
Seeking a career-building opportunity? The Director, Global Clinical Operations Quality Management position is now open for candidates interested in the Operations Executive Jobs sector. This role in New Delhi offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Operations Executive Jobs is a plus.
