Senior Specialist, QA Program Management

Senior Specialist, QA Program Management

We are LOTTE BIOLOGICS !
Delivering Therapies That Enable a Healthier World
.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science
, Embracing Diversity
, Fostering Talent
, and Connecting Lives
. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

Position Summary

The Sr. Specialist, QA Program Management is responsible for executing and supporting client-related Quality Assurance activities within a CDMO environment, providing quality oversight to internal stakeholders during new product introductions, technical transfers, and lifecycle management for existing products. This role supports client programs by ensuring internal alignment with site procedures, client requirements and Quality Agreements by applying specialized knowledge of cGMP regulations.

The role executes assigned QA deliverables, including document review and approval, and provides on-the-floor manufacturing Quality oversight to ensure compliant and efficient operations. This role is responsible for the execution and QA oversight of deviations, ensuring timely investigation, documentation, and closure, as well as supporting and overseeing client-specific change control activities, including recommendation, review, and approval of actions. The Sr. Specialist also supports implementation of client requirements through internal processes and contributes to broader site Quality and operational initiatives as needed.

This role requires the application of scientific and quality principles to interpret established standards, assess documentation and quality information, and support compliant decision-making in a cGMP-regulated environment.

Duties & Responsibilities

• Execute assigned QA activities for the Quality organization to enable successful new product introductions (NPI) and technical transfer projects, and lifecycle management activities in accordance with cGMP requirements, site procedures, client requirements, and Quality Agreements.
• Review assigned activities and documentation for alignment with Quality Agreements, site procedures, and client requirements; identify gaps and recommend required actions, escalation, or client notification for appropriate Quality review.
• Issuance of Quality-related Client Notifications and escalations through appropriate channels
• Draft, review, and maintain Quality Agreements by gathering inputs, identifying gaps, tracking deliverables, and routing agreements for appropriate review and approval for new and existing clients in alignment with internal processes and regulatory requirements.
• Participate in inspection and audit readiness activities by audit team participation as needed, reviewing assigned records, identifying potential compliance gaps, and recommending corrective actions for review. Serve as a QA representative during audits and inspections as assigned, providing factual information and supporting responses in coordination with senior Quality personnel.
• Drive execution of client-specific change control activities, including impact assessments, record review, and action tracking, in alignment with internal procedures.
• Perform QA review of site deviations and CAPAs, supporting thorough investigation, root cause analysis, and timely closure.
• Support preparation of Annual Product Quality Reviews (APQRs) to ensure ongoing process consistency and compliance.
• Review assigned NPI-related documentation such as Master Batch Records (MBRs) SOPs, BOMs, protocols, reports, and SOPs, for completeness, accuracy, and alignment with established requirements; identify issues and recommend revisions.
• Review process validation documentation (e.g., protocols and reports) to support compliance with regulatory and client requirements.
• Provide manufacturing Quality oversight, advising manufacturing operations to ensure adherence to GMP, procedures, and operational standards.
• Collaborate with cross-functional teams to communicate QA expectations, clarify procedural requirements, support timely completion of assigned…