Quality Operation Manager (GMP)

Sobi•San Diego, CA

About The Position

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.

Requirements

Bachelor’s degree (BS) or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Biomedical Sciences, or related field).
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 standard
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.

Nice To Haves

Experience with validating eQMS platforms and computerized system validation (CSV/CSA) is a plus.
This role may require occasional travel to vendor sites or regulatory agency meetings.
The Quality Manager may serve as Management Representative for the Quality System, where applicable.
This is a critical role supporting company growth, regulatory milestones, and long-term commercial success.

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
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.