About the job
The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS). This position is essential for ensuring that the Quality System effectively supports all phases of drug development, including nonclinical and clinical development, regulatory submissions (IND, NDA/BLA), commercialization, and product lifecycle management.
The Quality Operations Manager is tasked with maintaining compliance with relevant GxP requirements (GLP, GCP, GMP), FDA regulations, global standards, and industry best practices. This role also emphasizes readiness for inspections, regulatory submissions, vendor oversight, and the promotion of a quality-centric culture throughout the organization.
Key Responsibilities:
- eQMS Transition:
- Evaluate current paper-based procedures and devise a comprehensive plan for transitioning to electronic workflows.
- Ensure data integrity, compliance with Part 11 where necessary, and proper system validation.
- Facilitate the integration of GxP processes across all functional areas into a cohesive, risk-based framework.
- Quality System Management:
- Develop, implement, and uphold procedures for document control, training management, handling deviations and nonconformances, CAPA, change control, risk management, audit management, and complaint handling (if applicable).
- Coordinate and deliver training on GxP procedures.
- Support for External Quality Operations: If applicable.
- Inspection Readiness & Regulatory Interface:
- Lead inspection readiness initiatives across the organization.
- Manage regulatory agency inspections (e.g., FDA, EMA, and other global authorities).
- Oversee the timely and effective development and implementation of CAPAs in response to regulatory findings.
- Cross-Functional Leadership:
- Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT, and Commercial teams.
- Provide training and foster a culture of quality across the organization.
- Act as a quality advisor to senior leadership.
