Senior QA Specialist: Quality Leadership in Biomanufacturing

Resilience US; Blue Ash (OH); On-site; USD 100,000 - 140,000; Full time

Job summary

Resilience US in Blue Ash, OH seeks a Senior Specialist, Quality Assurance to lead QA oversight across manufacturing, inspection, and packaging. The role ensures cGMP compliance and supports product release activities, with collaboration across departments to improve quality and process efficiency.

The ideal candidate brings strong QA leadership, regulatorily aware mindset, and experience with audits, investigations, and continuous improvement in a pharmaceutical environment.

Qualifications

• Strong QA oversight across manufacturing and QC.
• Experience with cGMP and regulatory standards.
• Knowledge of 21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, ICH.
• Experience with design controls and change management.
• Leadership and cross-functional collaboration.

Responsibilities

• Provide quality oversight and approval for manufacturing, laboratory, and quality system activities.
• Ensure compliance with cGMP and regulatory standards through documentation reviews and quality systems monitoring.
• Review initial impact assessments to classify deviations.
• Support investigations with root cause analyses and CAPAs.
• Act as Quality SME for cross‑functional projects, audits, and regulatory interactions.
• Review and maintain quality documents, records, and validation materials.
• Support incoming material quality activities including inspection and release decisions.
• Collaborate with Manufacturing, Technical Operations, Supply Chain, and Quality teams.

Skills

Quality Assurance

Regulatory compliance

cGMP

Leadership

Audits & inspections

Tools

SAP

MAXIMO

CMMS

Electronic quality management systems

Job description

Resilience US in Blue Ash, OH seeks a Senior Specialist, Quality Assurance to lead QA oversight across manufacturing, inspection, and packaging. The role ensures cGMP compliance and supports product release activities, with collaboration across departments to improve quality and process efficiency.

The ideal candidate brings strong QA leadership, regulatorily aware mindset, and experience with audits, investigations, and continuous improvement in a pharmaceutical environment.