Technical Quality Lead - Validation & Compliance

Resilience, Inc.; Olde West Chester (OH); On-site; USD 100,000 - 144,000; Full time

Job summary

Resilience, Inc. is seeking a Technical Quality Senior Specialist II in Ohio to lead quality oversight across investigations, validation, and technology transfer. You will collaborate with MSAT, Engineering and Project Management to ensure GMP and regulatory compliance throughout product lifecycles.

The role requires advanced technical expertise, leadership, and the ability to drive continuous improvement in manufacturing quality and efficiency. Travel up to 10% may be required.

Qualifications

• Strong technical experience in qualification of equipment, utilities, facilities, technology transfer and process validation.
• Experience supporting audits and regulatory inspections.
• Knowledge of risk assessment tools (FMEA, HACCP, LOPA, PHA).
• Excellent problem-solving and written/verbal communication skills.
• Travel approximately 5-10% based on project demand.

Responsibilities

• Provide quality oversight for investigations, validation protocols, and technology transfer documents, ensuring adherence to specifications, procedures, and regulatory requirements.
• Review and approve complex validation documents including plans, URS/FS/SRA/SLIA/ACA, protocols, data analysis, discrepancies, and final reports.
• Represent the Technical Quality group in projects, audits, and inspections.
• Provide SME support during internal, regulatory, and customer audits and inspections.
• Lead major investigations with Lead Investigator and drive CAPAs and deviations.
• Drive continuous improvement to enhance product quality and manufacturing efficiency.
• Ensure manufacturing operations comply with GMP, FDA, EMA, and ICH guidelines.
• Collaborate with MSAT, Project Management, Engineering and other departments.
• Review and approve new product introductions from a quality perspective.
• Lead risk assessments (e.g. sFMEA) and mitigation strategies.

Skills

Tech leadership

Quality oversight

Regulatory knowledge

Quality management systems

Strong communication

Tools

Microsoft Office

Job description

Resilience, Inc. is seeking a Technical Quality Senior Specialist II in Ohio to lead quality oversight across investigations, validation, and technology transfer. You will collaborate with MSAT, Engineering and Project Management to ensure GMP and regulatory compliance throughout product lifecycles.

The role requires advanced technical expertise, leadership, and the ability to drive continuous improvement in manufacturing quality and efficiency. Travel up to 10% may be required.