Manager - Clinical Process and Quality Manager

Drlogy; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Drlogy is looking for an experienced Manager - Clinical Process and Quality Manager to oversee clinical quality systems, process compliance, and audit readiness. The role involves leading clinical quality management activities, ensuring adherence to GCP guidelines and regulatory standards, and mentoring team members.

Ideal candidates will have strong skills in clinical process management, quality assurance, and risk mitigation, along with collaborative abilities across clinical teams.

Qualifications

• 5+ years of experience in clinical process and quality management.
• Strong knowledge of GCP, regulatory guidelines, and quality standards.
• Experience in developing and maintaining quality management systems.

Responsibilities

• Lead clinical process and quality management activities across clinical operations.
• Ensure compliance with GCP, regulatory guidelines, SOPs, and quality standards.
• Conduct quality reviews and process audits for clinical studies.

Skills

Clinical process management

Quality assurance

Regulatory compliance

Risk mitigation

Cross-functional collaboration

Job description

Manager - Clinical Process and Quality Manager

Experienced Manager – Clinical Process and Quality Manager responsible for overseeing clinical quality systems, process compliance, audit readiness, and operational excellence within clinical research and healthcare environments. Skilled in clinical process management, quality assurance, regulatory compliance, SOP governance, and risk mitigation. Adept at collaborating with cross-functional clinical teams to ensure adherence to GCP guidelines, regulatory standards, and quality requirements while driving continuous process improvements and operational efficiency.

Responsibilities

• Lead clinical process and quality management activities across clinical operations.
• Ensure compliance with GCP, regulatory guidelines, SOPs, and quality standards.
• Develop, implement, and maintain clinical quality management systems and procedures.
• Conduct quality reviews, process audits, and compliance assessments for clinical studies.
• Monitor deviations, CAPA, risk assessments, and quality metrics to ensure operational effectiveness.
• Collaborate with clinical operations, data management, pharmacovigilance, and regulatory teams.
• Support inspection readiness and coordinate responses to audit observations and regulatory findings.
• Review clinical documentation, study records, and trial processes for compliance accuracy.
• Identify process gaps and implement continuous improvement initiatives across clinical functions.
• Provide quality oversight during study startup, conduct, and closeout activities.
• Ensure proper training and adherence to clinical procedures and quality standards.
• Monitor vendor and CRO compliance with contractual and regulatory requirements.
• Prepare quality reports, dashboards, and management review presentations.
• Support implementation of process automation and quality enhancement initiatives.
• Mentor and guide team members on clinical quality practices, compliance expectations, and process improvements.