GMP Quality Operations Lead for CDMO & Compliance

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Manager, GMP Quality Operations to oversee day-to-day quality activities across external manufacturing networks, ensuring alignment with cGMP and Viking quality standards.

This role collaborates with Quality, Technical Operations/CMC, Regulatory Affairs, Supply Chain, and CDMOs to drive compliant release and investigations. The position involves hands-on QA for drug substance, drug product, and combination-product manufacturing, including batch review,

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related discipline.
• 7+ years of progressive experience in GMP Quality Operations within pharmaceutical or biotechnology organizations.
• Hands-on experience supporting external manufacturing/CDMO operations and cGMP requirements.

Responsibilities

• Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs.
• Manage deviations, OOS/OOT investigations, and CAPAs per cGMP and ICH guidelines.
• Review and approve GMP documentation, batch records, reports, and Quality/CMC documentation for regulatory submissions (IND/IMPD, NDA/MAA).
• Provide QA support for technology transfer and process validation activities.
• Disposition GMP batches and interface with QPs and CDMO Quality organizations to support release.
• Manage change controls with Quality, Regulatory Affairs, and SMEs.
• Support CDMO quality performance in line with Quality Agreements and GMP requirements.
• Drive continuous improvement and inspection readiness activities.
• Collaborate cross-functionally to support pre-approval inspection and commercial readiness at CDMOs.
• Participate in compliance discussions and implement corrective actions.

Skills

GMP Quality Operations

External manufacturing/CDMO

Quality oversight

Deviation & CAPA

Batch record review

Change control

Technology transfer

Process validation/PPQ

Regulatory submissions support

Education

Bachelor’s degree in Life Sciences/ Chemistry/ Engineering

Job description

Viking Therapeutics, Inc. is seeking a Manager, GMP Quality Operations to oversee day-to-day quality activities across external manufacturing networks, ensuring alignment with cGMP and Viking quality standards.

This role collaborates with Quality, Technical Operations/CMC, Regulatory Affairs, Supply Chain, and CDMOs to drive compliant release and investigations. The position involves hands-on QA for drug substance, drug product, and combination-product manufacturing, including batch review,