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.
