Remote Quality and Compliance Lead - Tech Transfer (PET)

Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma; United States; On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies is seeking a Specialist in Quality & Compliance - Technology Transfer to lead QA for technology transfer projects across the PET manufacturing network. The role requires coordinating TP plans, change controls, risk assessments, and GMP documentation while ensuring inspections readiness.

Ideal candidates have 5+ years in pharmaceutical quality, 3+ years in sterile operations, and strong knowledge of FDA/cGMP requirements.

Qualifications

• Bachelor's degree in science/engineering required; master's preferred.
• Minimum 5 years pharma quality experience including sterile operations.
• Experience leading technology transfer and change management activities.

Responsibilities

• Act as the Quality representative for technology transfer projects across PET sites.
• Review and approve TP Plans, Change Controls, risk assessments, validation docs, GMP records.
• Collaborate with Operations, Validation, and project teams for launches and site starts.
• Conduct quality gap assessments between transferring and receiving sites.
• Lead Quality Risk Assessments (ICH Q9) and ensure mitigation plans.
• Support training, qualification, validation, and documentation reviews for readiness.
• Review deviations, investigations, CAPAs related to tech transfer.
• Assist with customer audits and FDA inspections.
• Drive continuous improvement of quality systems in tech transfer.

Skills

Quality Assurance

Technology Transfer

cGMP

Risk Management

FDA inspections

Cross-functional collaboration

Education

Bachelor's Degree in Science/Engineering

Master's Degree preferred

Tools

IQ/OQ/PQ documentation

CSV

Validation documentation review

Job description

Jubilant Radiopharmacies is seeking a Specialist in Quality & Compliance - Technology Transfer to lead QA for technology transfer projects across the PET manufacturing network. The role requires coordinating TP plans, change controls, risk assessments, and GMP documentation while ensuring inspections readiness.

Ideal candidates have 5+ years in pharmaceutical quality, 3+ years in sterile operations, and strong knowledge of FDA/cGMP requirements.