Quality Operation Manager (GMP)

About the role

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.

Responsibilities

• 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
• Integrate or as appropriate, develop, implement, and maintain procedures for:
• 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.

Qualifications

• Education - Bachelor’s degree (BS) or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Biomedical Sciences, or related field).
• Experience - Direct experience of transitioning from paper-based systems to an Electronic Quality Management System (eQMS).
• Familiarity with - IND and NDA/BLA regulatory submissions
• Regulatory agency inspections and inspection readiness
• GxP environments (GLP, GCP, GMP)
• Several years of progressive Quality experience in the pharmaceutical or biotechnology industry.
• Demonstrated experience supporting multiple stages of drug development: research, clinical development, regulatory submission, commercialization, and lifecycle management.
• Working knowledge of applicable regulations including 21 CFR Parts 210, 211, 312, 820 (if applicable), ICH guidelines, and related global standards.
• Experience with validating eQMS platforms and computerized system validation (CSV/CSA) is a plus.

Personal Attributes

• Strong systems thinker with ability to integrate cross-functional processes.
• Hands-on execution capability.
• High attention to detail and strong documentation skills.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Proactive, organized, and capable of working in a fast-paced, evolving environment.
• Demonstrated integrity and commitment to quality and compliance.