Quality Operation Manager (GMP)

About the role

The Quality Operations Manager at Sobi is responsible for supporting the transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS). This role ensures compliance with GxP requirements, regulatory submissions, and inspection readiness.

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

Personal Attributes

• 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.

Additional Information

Compensation and Total Rewards at Sobi: Base salary range for this role is $112,000-$150,000. Short-term and long-term bonuses are also available. Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Sobi offers a competitive benefits package to support the health and happiness of its staff.