Manager, GMP Quality Operations

Scorpion Therapeutics; San Diego (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Travel up to 25%

Job summary

Scorpion Therapeutics seeks an experienced GMP Quality Operations Manager to oversee external manufacturing and testing activities for late-stage programs. You will ensure cGMP compliance across batch reviews, investigations, and product disposition, while driving tech transfer and validation readiness.

The role requires hands-on quality oversight, regulatory familiarity, and strong cross-functional collaboration with CDMOs and QPs to sustain operational excellence.

Qualifications

• Bachelor's in Life Sciences, Chemistry, Engineering, or related field.
• 7+ years in GMP Quality Operations within pharma/biotech.
• Hands-on experience with batch review, investigations, deviations, CAPA, and change control.
• Familiarity with small molecule manufacturing, sterile injectables, drug-device combos, and global GMP regulations (FDA, EMA, ICH).

Responsibilities

• Manage deviations, investigations, batch record reviews, change controls, and product disposition.
• Support technology transfer, process validation, and inspection readiness.
• Collaborate with CDMOs, QPs, and cross-functional teams to maintain quality and operational excellence.

Skills

GMP knowledge

Deviations & CAPA

Batch record review

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's in Life Sciences/Engineering

Job description

Role

GMP Quality Operations Manager overseeing external manufacturing and testing activities supporting late-stage clinical and commercial biopharma programs.

Responsibilities

• manage deviations, investigations, batch record reviews, change controls, and product disposition


• ensure compliance with cGMP, ICH, and regulatory standards


• support technology transfer, process validation, and inspection readiness


• collaborate with CDMOs, QPs, and cross-functional teams to maintain quality and operational excellence

Requirements

• Bachelor's in Life Sciences, Chemistry, Engineering, or related field


• 7+ years in GMP Quality Operations within pharma/biotech


• hands-on experience with batch review, investigations, deviations, CAPA, and change control


• familiarity with small molecule manufacturing, sterile injectables, drug-device combos, and global GMP regulations (FDA, EMA, ICH)

Preferred

• experience supporting late-stage clinical or commercial manufacturing, external CDMO oversight, and technology transfer


• knowledge of scale-up, process validation, and product release

High Value

late-stage clinical and commercial manufacturing, GMP compliance, CDMO interface, sterile and combination products, global regulatory standards, 25% travel.

Work Setup

onsite in San Diego, CA; periodic travel.