Quality Operation Manager (GMP)

The Quality Operations Manager is responsible for supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS). This role ensures that the Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management. The Quality Operations Manager will ensure compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices.

The position supports inspection readiness, regulatory submissions, vendor oversight, and efforts to foster a culture of quality and compliance across the organization.

Key Responsibilities/Scope of the Job:

• eQMS Transition
  • Assess existing paper-based processes and develop a phased transition plan to electronic workflows.
  • Ensure data integrity, Part 11 compliance (where applicable), and appropriate system validation.
  • Support Integration of GXP processes across all GXP functional areas into a unified, risk-based framework.
• Quality System Management
  • Integrate or as appropriate, develop, implement, and maintain procedures for:
    • Document control
    • Training management
    • Deviations and nonconformances
    • CAPA
    • Change control
    • Risk management
    • Audit management
    • Complaint handling (if applicable)
  • Distribute and coordinate training of GXP procedures
• Support for External Quality Operation, if applicable
• Inspection Readiness & Regulatory Interface Support
  • Inspection readiness programs across the organization.
  • Regulatory agency inspections (e.g., FDA, EMA, other global authorities).
  • Oversee timely and effective CAPA development and implementation in response to regulatory findings.
• Cross-Functional Leadership
  • Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT and Commercial teams.
  • Provide training and promote quality culture across the organization.
  • Serve as a quality advisor to senior leadership.