GMP Quality Operations Lead — CDMO Partnerships

Socket.dev; San Diego (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

Viking Therapeutics, Inc. seeks a Manager of GMP Quality Operations to oversee day-to-day quality oversight across external manufacturing and testing networks supporting late-stage clinical and future commercial programs.

The role collaborates with Quality, Regulatory, and CDMOs to ensure cGMP compliance and readiness for inspections. The candidate will manage deviations, investigations, CAPAs, change control, and technology transfer, with experience in batch disposition and regulatory

Qualifications

• Bachelor’s degree required in Life Sciences or related field.
• 7+ years of progressive GMP Quality Operations experience in pharma/biotech.
• Experience supporting external manufacturing/CDMO operations preferred.
• Experience with GMP batch record review, investigations, deviations, CAPA, change control, and product disposition.
• Knowledge of technology transfer, process validation/PPQ, and manufacturing scale-up.
• Experience interfacing with Qualified Persons (QPs) and global product-release functions desirable.
• Strong understanding of FDA/EMA/ICH GMP regulations.

Responsibilities

• Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs.
• Oversee deviations, OOS/OOT investigations, and CAPAs per cGMP and ICH guidelines.
• Review and approve GMP documentation, including batch records and regulatory submissions support.
• Provide QA support for technology transfer and process validation activities.
• Dispostion GMP batches and interface with QPs and CDMO Quality organizations for product release.
• Manage change controls with stakeholders to ensure proper evaluation of changes.
• Support CDMO quality performance per Quality Agreements and GMP requirements.
• Drive continuous improvement and readiness for inspections.
• Collaborate cross-functionally to support pre-approval inspections and commercial readiness at CDMOs.
• Escalate quality risks and ensure corrective actions as needed.

Skills

GMP knowledge

Quality oversight

CDMO collaboration

Regulatory submission support

Project management

Communication skills

Education

Bachelor’s degree in Life Sciences or related

Job description

Viking Therapeutics, Inc. seeks a Manager of GMP Quality Operations to oversee day-to-day quality oversight across external manufacturing and testing networks supporting late-stage clinical and future commercial programs.

The role collaborates with Quality, Regulatory, and CDMOs to ensure cGMP compliance and readiness for inspections. The candidate will manage deviations, investigations, CAPAs, change control, and technology transfer, with experience in batch disposition and regulatory