Remote Senior Specialist, External Quality Ops

Keenova Therapeutics plc; Bridgewater, Northern (MA, KY); Hybrid; USD 80,000 - 129,000; Full time

Benefits offered by this job

Total Rewards package

Bonus eligibility

Job summary

Keenova Therapeutics plc is seeking a Senior Specialist, External Quality Operations to support externally manufactured products in a fully remote role. You will manage CMOs, oversee batch documentation, and ensure timely manufacture and quality issue resolution.

The position requires a Bachelor’s degree in a scientific field and 5–7 years of quality systems experience, including deviations, change controls, and supplier qualification.

Qualifications

• Bachelor’s degree in a scientific discipline; +5–7 years’ experience as a Quality Specialist.
• Experience with Quality Systems including deviations, change controls, training, supplier qualification and document management systems.
• Knowledge of cGMP for pharmaceutical manufacturing and GDP and ISO 13485.

Responsibilities

• Batch review and approval of CMO documentation for batch production.
• Oversee CMO governance and management of third‑party activities.
• Quality record management, deviations, changes, CAPAs and document control.
• Monitor cold-chain transportation and ensure qualification and routine checks.
• Manage audits, readiness, and continuous improvement projects with CMOs and Keenova.

Skills

Quality Systems

cGMP Knowledge

GDP Knowledge

ISO 13485 Knowledge

Documentation Management

Education

Bachelor’s Degree in scientific discipline

Tools

Document Management Systems

Job description

Keenova Therapeutics plc is seeking a Senior Specialist, External Quality Operations to support externally manufactured products in a fully remote role. You will manage CMOs, oversee batch documentation, and ensure timely manufacture and quality issue resolution.

The position requires a Bachelor’s degree in a scientific field and 5–7 years of quality systems experience, including deviations, change controls, and supplier qualification.