Quality Manager – Clinical

About the role

The Quality Manager will lead quality initiatives across clinical operations, ensuring compliance with GxP guidelines, local regulations, and sponsor requirements. This role works independently, providing expert advice, mentorship, and training to quality specialists while supporting audits, inspections, and corrective actions.

Key responsibilities

• Identify process improvement opportunities and champion their implementation.
• Provide expert advice and mentorship to quality specialists and functional leads.
• Participate in SOP, process, and quality‑related tool development.
• Conduct and oversee targeted or independent quality assessments.
• Verify compliance with GxP, local regulations, protocols, and internal procedures.
• Support audit and inspection preparation, representation, and response review.
• Manage quality issues, corrective and preventive actions (CAPA), and ensure their resolution.
• Perform process‑lead duties for enterprise or growth accounts as assigned.
• Attend and lead internal quality‑focused meetings.
• Maintain familiarity with Parexel systems, SOPs, and relevant regulations.
• Travel internationally approximately 10% of the time.

Required profile

• Ability to work independently and provide expert quality advice.
• Experience delivering mentorship, training, and leadership to quality teams.
• Willingness to travel internationally (≈10%).
• Strong understanding of GxP compliance and audit processes.

Required skills

• Knowledge of GxP guidelines and regulatory requirements.
• Experience with audit and inspection support.
• Familiarity with CAPA programs and quality assessment tools.