Director, Global Clinical Operations Quality Management
When our values align, there's no limit to what we can achieve.
At Parexel, we all 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 what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.