Senior GMP Quality Operations Leader

Viking Therapeutics; Northern, San Diego (KY, CA); Hybrid; USD 110,000 - 135,000; Full time

Job summary

Viking Therapeutics, Inc. in San Diego, CA, is seeking a Manager of GMP Quality Operations to oversee day-to-day quality activities across the external manufacturing network supporting late-stage clinical programs.

You will collaborate with Quality, CMC, Regulatory Affairs, and CDMOs to ensure compliant manufacturing, testing, and release, including deviations, CAPAs, change controls, and inspections readiness; travel ~25%.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field.
• 7+ years of GMP Quality Operations experience.
• Experience with external CDMOs and regulatory submissions is preferred.

Responsibilities

• Manage external Quality Operations activities for GMP manufacturing.
• Oversee deviations, OOS/OOT investigations, and CAPAs.
• Review GMP documentation including batch records and reports.
• Support technology transfer, process validation, and PPQ.
• Ensure inspection readiness and regulatory submissions support.
• Collaborate cross-functionally with QMS, Regulatory, and CDMOs.

Skills

GMP Quality Ops

CDMO coordination

Deviation investigations

Batch record review

CAPA management

Tech transfer

Process validation

Regulatory liaison

Documentation review

Education

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field

Job description

Viking Therapeutics, Inc. in San Diego, CA, is seeking a Manager of GMP Quality Operations to oversee day-to-day quality activities across the external manufacturing network supporting late-stage clinical programs.

You will collaborate with Quality, CMC, Regulatory Affairs, and CDMOs to ensure compliant manufacturing, testing, and release, including deviations, CAPAs, change controls, and inspections readiness; travel ~25%.