The Manager, GMP Quality Operations is responsible for day-to-day Quality oversight of GMP manufacturing and testing activities across Viking’s external manufacturing network, supporting late-stage clinical development and future commercial programs.

The Manager will work closely with Viking Quality, Technical Operations/CMC, Regulatory Affairs, Supply Chain, and external CDMOs to ensure manufacturing, testing, and release activities are executed in compliance with cGMP requirements, Quality Agreements, and Viking quality standards.

This role will provide hands-on Quality Operations support across drug substance, drug product, and combination-product manufacturing activities, including batch record review and disposition, deviation and investigation management, change control, technology transfer, process validation/PPQ, and inspection readiness.

This is an onsite role based in San Diego, CA, with periodic travel to domestic and international CDMOs as required.

Travel: ~25%

Essentials Duties and Responsibilities

The main responsibilities of this role include:

Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs.
Manage deviations, OOS/OOT investigations, and CAPAs in accordance with cGMP requirements and ICH guidelines.
Review and approve GMP documentation, including batch records, analytical and technical reports, and Quality/CMC documentation supporting regulatory submissions (e.g., IND/IMPD and NDA/MAA).
Provide QA support for technology transfer and process validation activities.
Perform disposition of GMP batches and interface with Qualified Persons (QPs) and CDMO Quality organizations to support product release.
Manage change controls to ensure appropriate evaluation of manufacturing- and testing-related changes by Quality, Regulatory Affairs, and relevant subject matter experts.
Support management of CDMO quality performance in accordance with Quality Agreements and GMP requirements.
Drive continuous improvement and inspection readiness activities.
Collaborate cross-functionally to support pre-approval inspection and commercial readiness activities at CDMOs.
Participate in compliance discussions and support the resolution of quality issues and implementation of required corrective actions.
Foster a culture of collaboration, accountability, and operational excellence across internal and external teams.
Perform additional tasks as assigned

Viking Therapeutics

Open Vacancies (1)

Manager, GMP Quality Operations