Director - Global Clinical Operations Quality Management

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.

Experience Level

Executive Level