Radiopharma QA Manager - cGMP & FDA Readiness

Pharmalogic Holdings; Austin (TX); On-site; USD 90,000 - 150,000; Full time

Job summary

PharmaLogic is seeking a hands-on Quality Assurance Manager to ensure cGMP compliance and oversee QA activities for PET radiopharmaceutical manufacturing. The role requires managing batch release, investigations, CAPAs and audits, while training staff and maintaining documentation.

The site leader for regulatory inspections will coordinate with management to sustain inspection readiness and robust QA processes across manufacturing and QC functions.

Qualifications

• BS/BA degree in a relevant scientific discipline and a minimum of 3–5 years Quality experience in the pharmaceutical industry.
• Strong knowledge of cGMP regulations and quality systems.
• Experience with batch review, release, deviations, CAPA and inspection readiness.

Responsibilities

• Ensure compliance with all regulatory commitments and SOPs including cGMP and radiation safety.
• Oversee production operations to ensure PET drugs meet identity, strength, quality and purity.
• Review batch, laboratory and production records before release; authorize or reject batches per SOPs.
• Lead FDA inspections and maintain audit readiness for the site.
• Provide QA training and maintain documentation for staff training and qualification.

Skills

QA Oversight

Regulatory knowledge

Cross-functional

Education

BS/BA in Science

Job description

PharmaLogic is seeking a hands-on Quality Assurance Manager to ensure cGMP compliance and oversee QA activities for PET radiopharmaceutical manufacturing. The role requires managing batch release, investigations, CAPAs and audits, while training staff and maintaining documentation.

The site leader for regulatory inspections will coordinate with management to sustain inspection readiness and robust QA processes across manufacturing and QC functions.