Manager - Development Quality Assurance

Drlogy; Gurugram District; On-site; INR 1,000,000 - 2,000,000; Full time

Job summary

Drlogy in Gurugram is seeking an experienced Manager – Development Quality Assurance to oversee quality assurance activities during product development and technology transfer in regulated pharmaceutical environments.

The ideal candidate will lead compliance with GMP and GLP standards, mentor the quality team, and ensure data integrity throughout development processes. Strong skills in regulatory standards and collaboration with cross-functional teams are essential.

Qualifications

• Experience in overseeing quality assurance activities in regulated pharmaceutical or healthcare environments.
• Skilled in quality systems and compliance management.
• Ability to collaborate with cross-functional teams.

Responsibilities

• Lead development quality assurance activities across product development.
• Ensure compliance with GMP and regulatory guidelines.
• Conduct internal audits and support regulatory inspections.
• Mentor quality assurance team members.

Skills

Quality systems

Compliance management

Risk assessment

Audit readiness

Regulatory standards

Job description

Job Overview

Experienced Manager – Development Quality Assurance responsible for overseeing quality assurance activities during product development, technology transfer, validation, and commercialization processes within regulated pharmaceutical or healthcare environments. Skilled in quality systems, compliance management, risk assessment, audit readiness, and regulatory standards. Adept at collaborating with cross‑functional teams to ensure product quality, data integrity, and adherence to GMP and development quality requirements throughout the product lifecycle.

Responsibilities

• Lead development quality assurance activities across product development and technology transfer stages.
• Ensure compliance with GMP, GLP, regulatory guidelines, and internal quality standards.
• Review and approve development documents, protocols, reports, and validation records.
• Support formulation development, analytical development, and process development quality oversight.
• Monitor change controls, deviations, CAPA, and risk management activities.
• Collaborate with R&D, manufacturing, regulatory affairs, and quality control teams.
• Ensure data integrity and documentation compliance throughout development processes.
• Participate in technology transfer and scale‑up activities to ensure quality compliance.
• Conduct internal audits and support external regulatory inspections and customer audits.
• Review qualification, validation, and stability study documentation for compliance accuracy.
• Identify quality risks and implement preventive and corrective action strategies.
• Drive continuous improvement initiatives to strengthen development quality systems.
• Maintain quality metrics, audit reports, and compliance dashboards for management review.
• Provide training and guidance on quality assurance procedures and regulatory expectations.
• Mentor and support quality assurance team members to improve operational effectiveness and compliance standards.