Senior Technical Quality Leader

Resilience US; Olde West Chester (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Resilience US is seeking a Technical Quality Senior Specialist II to ensure technical and operational quality, lead investigations, and drive continuous improvement in manufacturing processes. This role requires leadership across departments and expert QA oversight of validations, technology transfer, and regulatory compliance.

Responsibilities include reviewing validation plans and reports, supporting audits, and guiding risk assessments while ensuring adherence to GMP, FDA, EMA, and ICH

Qualifications

• Extensive QA/validation experience in GMP-regulated environments.
• Strong knowledge of regulatory expectations for technology transfer and validation.
• Experience supporting audits and regulatory inspections.
• Root-cause analysis and technical troubleshooting skills.

Responsibilities

• Provide quality oversight for complex investigations, validation, and tech transfer.
• Review and approve complex validation documentation and reports.
• Represent QA in projects, audits, and inspections as SME.
• Support audits, host during regulatory/customer inspections, and implement CAPAs.
• Lead major investigations with timely corrective actions and risk mitigations.
• Drive continuous improvement to enhance product quality and process efficiency.
• Ensure compliance with GMP, FDA, EMA, and ICH guidelines.

Skills

Quality oversight

Regulatory compliance

Leadership

Audits

FMEA

QMS

Cross-functional

Technical writing

Education

Bachelor's degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field

Tools

MS Office

QMS software

Job description

Resilience US is seeking a Technical Quality Senior Specialist II to ensure technical and operational quality, lead investigations, and drive continuous improvement in manufacturing processes. This role requires leadership across departments and expert QA oversight of validations, technology transfer, and regulatory compliance.

Responsibilities include reviewing validation plans and reports, supporting audits, and guiding risk assessments while ensuring adherence to GMP, FDA, EMA, and ICH