Late-Stage GMP Quality Ops Lead (CDMO Partnerships)

Regulatory Toolkit; 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 oversight of GMP manufacturing and testing across the external network.

You will ensure compliance with cGMP, QA documentation, and regulatory submissions, while supporting late-phase development and future commercial programs. You will lead deviations, investigations, CAPAs, change control, tech transfer, and batch disposition, coordinating with QPs, CDMOs, and internal teams to drive quality

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related discipline required.
• 7+ years of progressive GMP Quality Operations experience in pharma/biotech.

Responsibilities

• Oversee external Quality Operations for GMP manufacturing across clinical and future commercial programs.
• Manage deviations, OOS/OOT investigations and CAPAs per cGMP and ICH guidelines.
• Review and approve GMP documentation (batch records, analytical/technical reports) for regulatory submissions (IND/IMPD, NDA/MAA).
• Provide QA support for technology transfer and process validation activities.
• Disposition GMP batches and coordinate with QPs and CDMO QA functions for release.
• Manage change controls with QA, Regulatory, and SMEs.
• Oversee CDMO quality performance per Quality Agreements and GMP requirements.
• Drive continuous improvement and inspection readiness activities.
• Collaborate cross-functionally for pre-approval and commercial CDMO readiness.
• Participate in compliance discussions and implement corrective actions.
• Foster collaboration, accountability, and operational excellence across teams.

Skills

External CDMO ops

Late-stage clinical/commercial

GMP batch review

Investigations & CAPA

Change control & tech transfer

Process validation/PPQ

Drug substance/product manufacture

QPs interface

Regulatory awareness (FDA/EMA/ICH)

Project management

Excellent communication

Education

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

Job description

Viking Therapeutics, Inc. is seeking a Manager, GMP Quality Operations to oversee day-to-day quality oversight of GMP manufacturing and testing across the external network.

You will ensure compliance with cGMP, QA documentation, and regulatory submissions, while supporting late-phase development and future commercial programs. You will lead deviations, investigations, CAPAs, change control, tech transfer, and batch disposition, coordinating with QPs, CDMOs, and internal teams to drive quality